Histologic documentation: pathologic confirmation of invasive breast cancer by core or surgical biopsy (fine-needle aspiration [FNA] alone is not adequate)
Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS) or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer
Operable invasive breast cancer
Synchronous bilateral breast cancer at the time of diagnosis
Ipsilateral breast had a previous cancer and/or prior in-field radiation
No previous history of breast cancer (DCIS or invasive cancer) in either breast prior to current DCIS diagnosis
Unilateral DCIS: contralateral normal mammogram ? 6 months of registration and ipsilateral breast imaging ? 90 days of registration (must include ipsilateral mammogram; can also include ultrasound or breast MRI)
Bilateral DCIS: bilateral breast imaging ? 90 days of registration (must include bilateral mammogram; can also include ultrasound or breast MRI)
Concurrent diagnosis of invasive or microinvasive breast cancer in either breast
Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer\r\n* A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy)\r\n* Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study\r\n* Bilateral breast carcinoma is allowed provided either:\r\n** Diagnoses are synchronous – that is, within 3 months of one another – and at least one of the two breast carcinomas meet the eligibility criteria and neither is Her-2 positive or inflammatory; OR\r\n** The contralateral breast cancer was at least 5 years prior to the current diagnosis\r\n* No evidence of metastatic disease
No history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable)
Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed\r\n* Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant\r\n* Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants\r\n* Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: the tumor with the highest recurrence score should be used)
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days
T4 tumors including inflammatory breast cancer
Synchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)
Chemotherapy administered for the currently diagnosed breast cancer prior to randomization
No inflammatory breast cancer
No prior history of ipsilateral breast cancer (invasive disease or ductal carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
No history of prior or concurrent contralateral invasive breast cancer; benign breast disease; LCIS or DCIS of contralateral breast is allowed
For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration /randomization
Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery; residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring >= 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination; please note that in patients that have multifocal or multicentric residual tumors these lesions cannot be added up; the biggest lesion has to measure >= 1 cm in diameter; this is required due to constraints in deoxyribonucleic acid (DNA) extraction for PAM50 analysis\r\n* NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast\r\n* NOTE: Despite lymph node involvement if residual invasive cancer in the breast is < 1 cm in diameter patients are not eligible for participation
No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort
Patients must have metastatic and/or recurrent (distant or locoregionally recurrent) breast cancer and be HER2 non-over expressing per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by immunohistochemistry [IHC]; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by in-situ hybridization [ISH])\r\n* Local Regional Recurrence\r\n** In the breast (after preserving therapy)\r\n** In the chest wall (after mastectomy)\r\n** In the ipsilateral/parasternal/infra-or supraclavicular lymph nodes\r\n** In the skin of the chest wall (not breast)\r\n** In the reconstructed breast
Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
Clinical T2-T4c, any N, M0 invasive breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node\r\nPrimary tumor must be:\r\n* Palpable\r\n* Its largest tumor diameter is > 2.0 cm by physical examination or by radiological assessment\r\n* Bi-dimensional measurement by tape, ruler or caliper technique must be provided\r\n** Note:\r\n*** Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible\r\n*** Patients with multi-focal breast cancer (defined as more than one lesion of invasive breast cancer in the same breast separated from the dominant breast lesion by less than 5 cm of radiologically normal breast tissue) are eligible; if the other lesions have been biopsied (biopsy not required) they must meet the estrogen receptor/human epidermal growth factor receptor 2 (ER/HER2) eligibility requirements; research biopsies and Ki67 assessment and radiological measures are to be performed on the dominant breast lesion
Documentation of mammogram and ultrasound (including ductal carcinoma in situ [DCIS] and invasive cancer) of the diseased breast performed within 56 days prior to registration; mammogram for the unaffected contralateral breast is required within 12 months prior to registration
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)
An excisional biopsy of this breast cancer
Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion
History of invasive breast cancer or contralateral DCIS
T4 tumors including inflammatory breast cancer
Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible)
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible)
Any radiation therapy for the currently diagnosed breast cancer prior to randomization
Completed adequate breast surgery defined as:\r\n* The inked margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ with the exception of the posterior margin if this margin is the pectoralis major fascia or the anterior margin if this is the dermis; patients with resection margins positive for lobular carcinoma in situ are eligible\r\n* Patients with breast conservation must have adjuvant radiotherapy; patients having mastectomy may have adjuvant radiotherapy according to local policy and/or international guidelines
Pathologically confirmed metastatic breast cancer
Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer
Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and/or PR+ and HER2-.
Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.
Histologic documentation of invasive adenocarcinoma of the breast
T4 tumors including inflammatory breast cancer
Any history, not including the index cancer, of ipsilateral or contralateral invasive breast cancer or ipsilateral or contralateral DCIS treated with radiation therapy (RT)\r\n* Note: Patients with synchronous or previous ipsilateral LCIS are eligible
Any radiation therapy (RT) for the currently diagnosed breast cancer prior to study enrollment
History of ipsilateral or contralateral breast or thoracic RT for any condition
Synchronous contralateral breast cancer requiring RT
Overall geometry (eg, breast size if intact breast) precludes the ability to achieve dosimetric requirements \r\n* Note: Set-up devices for breast positioning are permitted
BRCA 1/2- associated metastatic breast carcinoma
Group 3: Triple negatice breast cancer.
Participants must have histologically or cytologically confirmed breast cancer, with diagnosed or suspected metastatic, inoperable locally advanced breast cancer, or inoperable locally recurrent breast cancer for which standard curative or palliative measures do not exist or are no longer effective
Patients who have had any prior chemotherapy, or endocrine therapy for the treatment of breast cancer or any other cancer
Patients with breast cancer and gastric and gastroesophageal junction cancer must have received at least 1 prior HER2 targeted therapy for advanced/metastatic disease.
No prior systemic treatment for metastatic breast cancer
Pathologic confirmation of metastatic breast cancer diagnosed by core needle biopsy
Expanded Cohort: must have breast cancer.
Recurrent ipsilateral breast cancer
Prior malignancy, other than breast cancer, active within the last 6 months
Triple negative breast cancer.
Triple negative breast cancer (TNBC)
Triple Negative Breast Cancer (TNBC) (D
For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
Locally recurrent breast cancer
Participants must have histologically confirmed invasive breast cancer; all histologic subtypes are eligible
Patients must have the clinical diagnosis of inflammatory breast cancer as evidenced by the onset of signs and symptoms noted below within a 6 month time-period:\r\n* Erythema of the breast\r\n* Edema of the skin of the breast\r\n* Enlargement of the breast
Patients may have bilateral breast cancer so long as one breast meets criteria for inflammatory breast cancer, and neither breast cancer has received prior therapy
Histologically documented HER2-positive and HER2-negative (cohort E only) breast cancer
Metastatic breast cancer that is measurable (Stage 1) or early breast cancer with a primary tumor size greater than (>) 2 centimeter (cm) (Stage 2)
All patients must be diagnosed with invasive breast cancer
Patients with inflammatory breast cancer are eligible if they meet both of the following criteria:\r\n* Patient has an underlying, clinically palpable breast mass of at least 2 cm, AND\r\n* A corresponding lesion is visualized on mammogram or ultrasound
Any prior systemic therapy for breast cancer within 5 years
Patients with known bilateral invasive breast cancer; patients with contralateral in situ breast carcinoma are eligible
Metastatic breast cancer (measurable or evaluable including bone metastases only)
Any number of prior therapies for metastatic breast cancer is allowed; patients with weakly estrogen receptor positive breast cancer who received any number of endocrine agents for metastatic breast cancer will also be eligible
Prior or concurrent use of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer, including any history of prior irradiation to the ipsilateral breast; additionally, the patient must not have had hormonal therapy for breast cancer treatment or for breast cancer prevention within 2 years prior to study enrollment; Note: Synchronous breast, cancer (including bilateral breast cancer) at separate sites is permissible, provided the patient does not receive medical treatments for breast cancer or radiation therapy to the ipsilateral breast during the 21 day study intervention period
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
Breast size adequate for safe cryoablation
Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC) 4. Presence of multifocal and/or multicentric in breast cancer 5. Presence of multifocal calcifications 6. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
Patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer; patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least one month prior to baseline study biopsy
Have metastatic breast cancer with severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
Metastatic non-gynecologic or breast primaries
Breast cancer patients
No prior chemotherapy or trastuzumab for treatment of metastatic breast cancer
Prior breast cancer or other invasive malignancy treated within 5 years
Clinical T2-T4c, any N, M0 invasive ER+ (Allred score of 6-8) and HER2 negative (0 or 1+ by immunohistochemistry [IHC] or fluorescent in situ hybridization [FISH] negative for amplification) breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node\r\n* Note: patients with invasive ER+ (Allred Score of 6-8) HER2- breast cancer or ductal carcinoma in situ (DCIS) in the contralateral breast the patient are eligible
PIK3CA WILD TYPE COHORT (closed 03/17/2016): Clinical T2-T4c, any N, M0 invasive ER+ (Allred score of 6-8) and HER2 negative (0 or 1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node\r\n* Note: patients with invasive ER+ (Allred score of 6-8) HER2- breast cancer or DCIS in the contralateral breast the patient are eligible
ENDOCRINE RESISTANT COHORT: Clinical T2-T4c at diagnosis or screening, any N, M0 invasive ER+ (Allred score at least 3 or > 1% ER positivity) and HER2 negative (0 or 1+ by IHC or FISH negative or equivocal) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node\r\n* Note: patients with invasive breast cancer that is ER positive (pos), HER2 negative (neg) or equivocal or DCIS in the contralateral breast are eligible; multi-focal diseases are not excluded; the dominant lesion will be followed per protocol
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer or localized breast cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Have a diagnosis of metastatic triple negative breast cancer (TNBC) • Up to 1-2 prior lines of chemotherapy
Histologically confirmed HER2-negative localized breast cancer by core biopsy.
Prior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registration
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
FNA alone to diagnose the breast cancer.
Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
Phase 1a: ISH positive or IHC 3+ advanced cancer (including breast or gastric/esophageal or other solid tumors).
Cohort 1: advanced breast cancer, ISH positive or IHC 3+.
Cohort 2: advanced breast cancer, ISH negative with IHC 2+.
Participant with inflammatory breast cancer.
Prior history of invasive breast cancer
Stage 4 (metastatic) breast cancer
Prior systemic therapy for treatment and prevention of breast cancer
History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancer
History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed >5 years prior to diagnosis of current breast cancer
Bilateral breast cancer
Cancer patients with stage 0-III breast cancer (BrCA) treated with breast conserving surgery or mastectomy and clear margins will be recruited to the study
Patients must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:\r\n* Prior chemotherapy for breast cancer\r\n* > 25 cm of breast separation (the largest distance on an axial slice of the planning computed tomography [CT] simulation scan between the entry and exit points of the radiation beam on the body)\r\n* Non-Caucasian race\r\n* Requiring regional nodal irradiation without evidence of N3 disease
Bilateral breast cancer is permitted; patients with bilateral breast cancer will be stratified as left-sided
Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast or thorax; individuals with prior radiotherapy in the contralateral breast or chest wall are eligible
Any radiation therapy for the currently diagnosed breast cancer prior to randomization
Patients with stage II-III breast cancer are eligible if they are deemed appropriate for neoadjuvant endocrine therapy by the referring or treating medical oncologist. Patients with stage I disease are eligible if they are deemed borderline candidates for breast conservation and the treating surgeon recommends preoperative therapy to increase the chances of breast conservation.
Patient must be willing to undergo breast biopsies as required by the study protocol.
HER2-overexpressing (3+ by IHC) or HER2 2+ and FISH positive breast cancer must have progressed after prior treatment with trastuzumab, pertuzumab, and T?DM1
advanced triple negative breast cancer,
Histologic confirmation of breast cancer resected by mastectomy with or without immediate reconstruction and chest wall and regional nodal irradiation planned
Radiotherapy must begin within 12 weeks of last surgery (breast or axilla) or last chemotherapy\r\n* Note: Breast implants and expanders allowed
Inflammatory breast cancer
Recurrent breast cancer
Patient has elected breast-conserving surgery (BCS) as surgical treatment for early-stage breast cancer
Patients must meet one of the following criteria:\r\n* Pre-pathology cohort: Patient has new diagnosis of breast cancer and has elected BCS; these patients must be consented prior to the scheduled BCS with precision breast IORT; BCS (either primary breast surgery or re-excision) will occur one same date as precision breast IORT\r\n* Post-pathology cohort: Patient was previously treated for breast cancer with BCS; precision breast IORT will occur as a separate procedure within 30 days of breast surgery; these patients should be consented after they have completed the initial excision and histological confirmation of eligibility
Breast cancer that involves the skin or chest wall
History of ipsilateral breast cancer treated with radiation therapy
Multicentric breast cancer in the ipsiltateral breast as diagnosed by clinical exam, mammogram, ultrasound or magnetic resonance imaging (MRI)
For patients in the post-pathology stratification, precision breast IORT must be delivered within 30 days of the last breast cancer surgery (not axillary)
Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular
Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.
Prior history of breast cancer.
Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or treatment of breast cancer or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ [DCIS]), or who receive aromatase inhibitors for prevention or treatment of breast cancer, are eligible; patients who are hormone-receptor positive and who have received other hormonal agents for the treatment of breast cancer (e.g., Fulvestrant) are also eligible; tamoxifen therapy or other hormonal agents should be discontinued at least 1 week before the patient is enrolled on this study
Prior breast cancer or other invasive malignancy treated within 5 years
Breast cancer\r\n* Infiltrating ductal carcinoma or ductal carcinoma in situ (DCIS), stage T0, T1, and T2 =< 3.0 cm, N0 and M0\r\n* Patients benefiting from high dose rate brachytherapy (HDR) as either as a boost or accelerated partial breast irradiation regimen
Breast cancer:\r\n* Patients inappropriate for standard breast conservation therapy (multicentric disease, inability to achieve clear margins)\r\n* Male patients with breast cancer\r\n* Autoimmune disorders, including systemic lupus erythematosus (SLE), scleroderma, etc\r\n* Distant metastases
Prior therapies for metastatic breast cancer\r\n* Frontline patients who have not received prior systemic therapy for metastatic breast cancer are eligible, \r\n* Patients who have received =< 2 prior chemotherapy regimens for metastatic breast cancer are eligible
Diagnosis of inflammatory breast cancer
Histologic confirmation of invasive breast cancer with any measures of ER, PR and HER2neu
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory biopsies
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients who have undergone radiotherapy within 4 weeks of first dose of study treatment
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients with a history of another invasive malignancy within the last 3 years
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients with bone metastases who have initiated denosumab or bisphosphonate therapy within 28 days prior to cycle 1 day 1
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients must have received at least one line of prior chemotherapy in the metastatic setting
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory biopsies
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: AST and ALT levels =< 3 X ULN
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients who have undergone radiotherapy within 4 weeks of first dose of study treatment
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients with a history of another invasive malignancy within the last 3 years
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients with bone metastases who have initiated denosumab or bisphosphonate therapy within 28 days prior to cycle 1 day 1
Clinical stage I-III breast cancer with any invasive residual disease in the breast or axillary nodes following neoadjuvant chemotherapy including HER-2 directed treatment
Women with metastatic breast cancer who are eligible for capecitabine monotherapy; for HER2 positive breast cancer, concurrent trastuzumab is allowed OR
Invasive cancer in the contralateral breast
Histologically confirmed invasive cancer of the breast
Presence of a clip in the primary breast cancer
Planned for multidisciplinary evaluation by a breast surgical oncologist and breast radiation oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon
Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
No prior radiation to the ipsilateral breast, a history of contralateral breast radiation is permitted
Multicentric breast cancer, defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue or discontiguous tumors that are located within separate breast quadrants either clinical or mammographically
Multifocal breast cancer, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5 cm, or within the same breast quadrant
Have histological confirmation of breast cancer with recurrent and/or metastatic lesions via investigational site which has failed prior therapy.
Male breast cancer patients. 19. Patients may not be on a concurrent clinical trial, unless approved by Investigator.
Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
Patients with metastatic breast cancer
Histological diagnosis of breast cancer
Planning to remain on current breast cancer therapy for at least 12 weeks
At least one prior line of therapy for metastatic breast cancer
Histologically confirmed breast cancer (infiltrating ductal or lobular breast carcinoma) with evidence of measurable metastatic disease; metastatic disease must be biopsy proven\r\n* Since histologic type, lymphatic permeation, blood vessel invasion, and degree of anaplasia may be prognostic variables, appropriate slides of the primary lesion will be requested for future review; HER2, estrogen, and progesterone receptor positivity will be recorded
Patients must have had at least one prior line of therapy for breast cancer in the metastatic setting
Patients must have an accessible lesion in the breast/chest wall/axilla which has not been previously thermally ablated; prior breast irradiation is acceptable if the lesion has recurred or grown following radiation
COHORT 1 (TRIPLE-NEGATIVE BREAST CANCER [TNBC])
Patients with ER+ breast cancer must have progressed on at least 2 lines of endocrine therapy
PTEN or PIK3CB mutated advanced solid tumor\r\n* PTEN loss of function mutation or PIK3CB gain of function mutation identified by local Clinical Laboratory Improvement Act (CLIA) certified next generation sequencing (NGS)\r\n* Breast cancers patients enrolled on this study must have either:\r\n** Estrogen receptor positive and HER2 negative breast cancer\r\n** Triple negative breast cancer
HER2 positive breast cancer
Pathologically confirmed DCIS of the breast
Plans to administer irradiation to the breast only
Histologic or clinical evidence of invasive breast cancer
Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
Synchronous bilateral breast cancer at the time of diagnosis
Prior history of breast cancer or in-field radiation in the ipsilateral breast
Confirmed diagnosis of inflammatory breast cancer according to international consensus criteria: (1) onset: rapid onset of breast erythema, edema, and/or peau d’orange, and/or warm breast, with or without an underlying breast mass (2) duration: history of such findings no more than 6 months (3) extent: erythema occupying at least 1/3 of whole breast (4) pathology: pathologic confirmation of invasive carcinoma
Histologically confirmed diagnosis of invasive breast cancer
Invasive cancer in the contralateral breast
Women must agree not to breast feed while on study
No prior breast or thoracic radiotherapy
Subjects must not have prior breast or thoracic radiotherapy
Breast cancer suitable for mandatory baseline core biopsy
No prior systemic therapy or radiotherapy for currently-diagnosed invasive or noninvasive breast cancer
Early stage (curable) breast cancer
Prior systemic therapy for invasive or non-invasive (DCIS) breast cancer
Prior radiotherapy to the ipsilateral chest wall or breast for any malignancy
Bilateral invasive breast cancer
FOR ALL PHASES (Ib AND II): Inflammatory breast cancer
Patients who had received therapy for metastatic breast cancer (other than that described above)
Patients must have a histologically confirmed HER2 positive breast cancer (by immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization [FISH] ratio >= 2.0)\r\n* Phase I: unresectable locally advanced or metastatic breast cancer\r\n* Phase II: clinical stage 2-3 early stage breast cancer
Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for the prevention or treatment of breast cancer or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ [DCIS]), or who receive aromatase inhibitors for prevention or treatment of breast cancer, are eligible; patients who are hormone-receptor positive and who have received other hormonal agents for the treatment of breast cancer (e.g., Fulvestrant) are also eligible; tamoxifen therapy or other hormonal agents should be discontinued at least 1 week before the patient is started on study therapy
Histological confirmation of breast cancer
Excisional biopsy or lumpectomy for the current breast cancer
Women with pathologically demonstrated breast cancer
Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer; however, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not Food and Drug Administration (FDA) approved for the treatment of the patient’s current breast cancer, are permitted
Histologic confirmation of ER+ breast cancer
More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer
Have histological confirmation of breast cancer with recurrent and/or metastatic lesions via investigational site.
Patients with new or progressive breast cancer metastatic to brain will be eligible provided:
Male breast cancer patients.
Histologically-confirmed, primary, invasive breast cancer diagnosed within 5 years of study entry
Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: subjects with multifocal/multicentric tumors are eligible). Subject must have (according to TNM 7th edition rules):
Multifocal disease within the breast
Patients for whom radiotherapy for breast cancer is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation)
Has histological confirmation of breast carcinoma.
Has confirmed inflammatory breast cancer by using international consensus criteria:\r\n* Onset: Rapid onset of breast erythema, edema and/or peau d’orange, and/or warm breast, with/without an underlying breast mass.\r\n* Duration: History of such findings no more than 6 months.\r\n* Extent: Erythema occupying at least 1/3 of whole breast.\r\n* Pathology: Pathologic confirmation of invasive carcinoma.
Distant metastasis that involves occurrence of breast cancer outside of locoregional breast and lymph nodes area.
Invasive adenocarcinoma of the breast diagnosed by core needle biopsy
Breast imaging performed prior to study registration as follows:\r\n* Ipsilateral breast – within 12 weeks\r\n* Contralateral breast – within 24 weeks
Breast cancer treatment for the currently diagnosed breast cancer including radiation therapy, chemotherapy, targeted therapy, or endocrine therapy prior to study registration
History of ipsilateral invasive breast cancer or ipsilateral ductal carcinoma in situ (DCIS); Note: patients with history of ipsilateral lobular carcinoma in situ (LCIS) are eligible
Patient desires breast conserving therapy
If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
Clinical evidence for a stage T3 or T4 breast cancer
Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)
Pathologically proven diagnosis of breast cancer
Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
Bilateral breast cancer
Ductal breast carcinoma in situ (DCIS) only
Male breast cancer
If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer
Pathologic or clinical evidence for a stage T4 breast cancer
Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast
Current diagnosis of bilateral breast cancer
History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
Breast feeding (if lactating, must agree not to breast feed while taking lenalidomide); breastfeeding should be discontinued if the mother is treated with lenalidomide
Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal
Prior systemic therapy for indexed breast cancer
Inflammatory breast cancer
Patients must have histologically confirmed invasive breast cancer (stages I-III) who have undergone core needle biopsy (clinically or radiographically at least T1c to allow adequate residual cancer tissue at surgery) and will be scheduled for surgical resection (i.e. segmental excision or mastectomy)
Patients must have histologically or cytologically confirmed stage IV breast carcinoma with a previous clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis
Patients must have histological confirmation of breast carcinoma
Patients must have invasive breast cancer (IBC), confirmed according to international consensus criteria:\r\n* Onset: Rapid onset of breast erythema, edema, and/or peau d’orange, and/or warm breast, with or without an underlying breast mass\r\n* Duration: History of such findings no more than 6 months\r\n* Extent: Erythema occupying at least 1/3 of whole breast\r\n* Pathology: Pathologic confirmation of invasive carcinoma
History of radiotherapy for current breast cancer diagnosis
Received any prior cancer therapy for the breast, uterine, or cervical cancer that is being resected, including progesterone therapy for endometrial cancer patients\r\n* Patients may have had prior therapy for other contra-lateral breast cancer
Has invasive breast cancer; this does not include microinvasion
Pregnant or need to breast feed during the study period
Have histological confirmation of HER2 positive breast cancer
Patients must not have received prior treatment for the current breast cancer
Planned neoadjuvant chemotherapy for breast cancer as determined by the judgment of the medical oncologist
Stage I-III non-metastatic breast cancer\r\n* Inflammatory breast cancer (T4d) is acceptable\r\n* Patients with oligo-metastatic disease who are being treated with a curative intent as per the treating physician are eligible as well
For LY3300054 + abemaciclib in HR+, HER- breast cancer:
Breast cancer survivors with a severe current psychiatric diagnosis (e.g. bipolar disorder)
No prior history of an invasive breast cancer
T4 tumors, known metastatic disease, recurrent disease, inflammatory breast cancer, multicentric disease, and/or synchronous bilateral breast cancer
gBRCAm HER2-negative metastatic breast cancer (module 2)
No prior therapy for current breast cancer and not planning neoadjuvant chemotherapy
Must have received no more than 2 lines of chemotherapy for the treatment of breast cancer, and one for the treatment of advanced breast cancer
Patients with histologically confirmed intact primary cancer that is confirmed invasive carcinoma of the breast, with at least 1.0 cm residual disease as measured by mammography, ultrasound, or breast magnetic resonance imaging (MRI) after neoadjuvant anthracycline based chemotherapy
Multicentric gross breast carcinoma (either DCIS or invasive cancer) or microscopic breast carcinoma occupying a volume with maximum dimensions of more than 3 centimeters
Synchronous bilateral invasive or non-invasive breast cancer
Locally recurrent resectable breast cancer
localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy;
Subjects have histologically confirmed adenocarcinoma of the breast - all breast cancer subtypes are allowed
Histologic documentation of breast cancer by core needle or incisional biopsy
Any other presurgical therapy for breast cancer
Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS within 1 month
Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy
Diagnosis of inflammatory breast carcinoma
Diagnosis of triple-negative or ER-negative breast cancer
Stage at diagnosis T2 through T4a-c, N0 through N2, and M0; patients with inflammatory breast cancer or metastatic disease at diagnosis will be excluded; patients with multicentric, multifocal, and/or bilateral disease are allowed to participate so long as all tumors meet the histologic criteria of the study
No prior treatment with therapeutic intent for breast cancer
Metastatic breast cancer
Inflammatory (T4d) breast cancer
Inoperable breast cancer even after neoadjuvant treatment as assessed by the treating surgical oncologist
Disease that cannot be measured and/or accurately followed by mammogram and/or breast ultrasound and/or dedicated breast MRI
Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same
Bilateral synchronous breast cancer
Previous history of breast cancer (even in the other breast)
Evidence of metastatic/stage 4 breast cancer
Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric disease preventing resection through a single incision, no pregnant women, and no comorbid conditions precluding surgery)
Breast implant in the breast to be treated (contralateral breast implant is acceptable)
Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
Breast implant in the breast to be treated with stereotactic body radiation therapy (SBRT)
Histologically proven unilateral or bilateral primary breast carcinoma; (in case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint)
Documentation of inflammatory breast cancer
Histologically confirmed diagnosis of invasive breast cancer
Clinical stage T2-T4c, any N, M0 primary tumor by American Joint Committee on Cancer (AJCC) 7th edition clinical staging prior to neoadjuvant chemotherapy, with residual invasive breast cancer after neoadjuvant therapy; if the patient has invasive cancer in the contralateral breast, she is not eligible for this study
Evidence of progressive breast cancer within the last 30 days
Invasive cancer in the contralateral breast
Has histological confirmation of HER2 normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless estrogen receptor (ER)/progesterone receptor (PR) status; OR has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR < 10%) without clinical diagnosis of IBC
Must have progressed on at least 1 prior systemic therapy regimen for the treatment of advanced breast or other non-breast metastatic cancer; there is no upper limit on the number of prior therapies
At least 10 HER2-negative breast cancer patients will be enrolled in this cohort
Patients must have either A) histologic documentation of metastatic or locally advanced breast cancer by core needle or incisional biopsy, or B) history of breast cancer with radiologic evidence of bone-only metastatic disease
Previously untreated breast cancer determined by a core needle biopsy showing invasive ductal carcinoma or invasive lobular carcinoma
A prior, unrelated, breast cancer is allowed
All stages of breast cancer are eligible
Inflammatory breast cancer or patients with rapidly progressing metastatic breast cancer
Histologically confirmed diagnosis of invasive breast cancer
Clinical stage T1c-T4c, any N, M0 primary tumor by American Joint Committee on Cancer (AJCC) 7th edition clinical staging prior to neoadjuvant chemotherapy, with residual invasive breast cancer after neoadjuvant therapy; if the patient has invasive cancer in the contralateral breast, she is not eligible for this study
Evidence of progressive breast cancer within the last 30 days
Invasive cancer in the contralateral breast
Diagnosis of inflammatory breast cancer
Patients must have histologic or cytologic confirmation of the diagnosis of invasive adenocarcinoma of the breast.
The patient must have clinical node negative, stage I breast cancer
COHORT II: The patient must have clinical node negative, stage I breast cancer
Hormone unresponsive breast cancer
Have no inflammatory breast cancers
Newly diagnosed clinical stage II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant chemotherapy as the treatment goal
Prior systemic therapy for the indexed breast cancer
Patients with bilateral or inflammatory breast cancer
Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis
Multifocal or multicentric invasive breast carcinoma
Prior or planned neoadjuvant systemic therapy for breast cancer
Subjects with histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy with a plan of surgical excision (goal: approximately 2 weeks of study medications after enrollment)
Pain that developed or worsened since breast cancer diagnosis and is not due to identifiable traumatic event or fracture
HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) >= 2.0 on breast specimen or biopsy of a metastatic site
No more than two prior cytotoxic chemotherapeutic regimens for metastatic breast cancer; in addition, prior trastuzumab emtansine (TDM-1, Kadcyla) is allowed
Histologically confirmed diagnosis of invasive or non-invasive breast cancer
Patients must have bilateral mammogram and/or breast magnetic resonance imaging (MRI) within 3 months of diagnosis of their breast cancer
Patients with synchronous bilateral breast cancers who will be treated with radiotherapy to each breast are eligible, provided such treatment can be performed in a manner that avoids overlap between treatment fields; both sides may be treated with accelerated partial breast irradiation (APBI) if the pathologic eligibility criteria are met for both tumors, or only one side may be treated with APBI if the criteria are met for only one tumor
Patients with a history of prior breast cancer in the opposite breast are eligible as long as treatment can be performed without overlapping any prior radiation therapy (RT) fields
Patients with a history of prior breast cancer in the ipsilateral breast treated with lumpectomy alone (no RT) are eligible as long as the other entry criteria for this study are met
Male breast cancer
Breast cancers with an extensive in-situ ductal component (defined as >= 25% of the tumor volume and DCIS present within and in the surrounding normal breast tissue of the invasive tumor)
Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or two or more breast cancers not resectable through a single lumpectomy incision
Prior therapy for breast cancer
Women already undergoing neoadjuvant chemotherapy to treat their primary triple negative breast cancer
Subjects must be females with a histological diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer clinical stage T0-3, N01 and be candidates for primary resection of this cancer; NOTE: subjects with bilateral cancer are eligible\r\n* Primary tumor stage T0-3 at the time of initial diagnosis and ipsilateral nodes must be N0-1 by clinical evaluation; staging is routinely based on the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and TNM Nomenclature for Breast Cancer from American Joint Committee on Cancer (AJCC) Cancer Staging Manual; all breast cancer patients routinely undergo axillary ultrasound to evaluate nodal involvement
Subjects must not have received any other breast cancer-specific therapy for the current breast cancer diagnosis prior to registration
Previous history of ipsilateral invasive breast cancer or DCIS.
Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral breast.
Patient must have had a bilateral mammogram prior to NAC unless there is only one breast
Patient must have > 1.0 cm residual in-breast cancer and/or clinically positive residual nodal disease
A known BRCA-associate genetic mutation OR family history suggesting of a breast or ovarian cancer syndrome, as defined by one or more of the following:\r\n* Personal or known family history of a deleterious (or indeterminate) mutation in the BRCA1, BRCA2, PALB2, or one of the FANC genes\r\n* Personal history of breast cancer and one or more of the following:\r\n** Diagnosed =< 45 years old\r\n** Diagnosed at any age with >= 1 1st, 2nd, or 3rd degree relative with breast cancer =< 50 years old and/or >= 1st, 2nd, or 3rd relative with epithelial ovarian cancer at any age\r\n** Two primary breast cancer with the first diagnosed at =< 50 years old\r\n** Diagnosed =< 60 years old with triple negative breast cancer\r\n** Diagnosed at any age with >= 2 1st, 2nd, or 3rd degree relatives with breast cancer at any age\r\n** Diagnosed at any age with >= 2 1st, 2nd, or 3rd degree relatives with pancreatic cancer or aggressive prostate cancer (Gleason score >= 7) at any age \r\n** 1st, 2nd, or 3rd degree male relative with breast cancer\r\n** Ashkenazi Jewish descent\r\n* Personal history of epithelial ovarian cancer\r\n* Personal history of male breast cancer\r\n* Personal history of pancreatic cancer and >= 2 1st, 2nd, or 3rd degree relatives with breast, epithelial ovarian, pancreatic, or aggressive prostate cancer (Gleason score >= 7) at any age
Addition inclusion for Part A (A6 & A7) Has a histological confirmation of either metastatic breast (ER+ve for Arm A6, 50% ER +ve and 50% HER2+ve metastatic breast cancer patients for Arm A7) or castrate-resistant prostate cancer
Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma.
Participants in Part F must have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases.
On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast
Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign
Synchronous bilateral invasive or non-invasive breast cancer
No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast; patients with a local recurrence of a previously excised phyllodes tumor are eligible if the recurrence is in the area of the previous excision
No history of irradiation of the ipsilateral breast
Breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
A history of irradiation to the ipsilateral breast
No histologic documentation of breast adenocarcinoma
Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
Any previously treated contralateral breast carcinoma or synchronous ipsilateral breast carcinoma
Prior radiation therapy for the current breast cancer
Histological documentation of advanced solid tumor, other than triple-negative breast cancer (TNBC).
Histologically confirmed invasive primary breast cancer
Inflammatory breast cancer
Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments); prior treatment for previous breast cancer or other neoplasms is allowed as long as it was completed at least 1 year prior to inclusion into this trial.
Women referred for breast conservation surgery following a diagnosis of invasive or in situ carcinoma of the breast by histopathology or women referred for lumpectomy due to a benign (fibroadenoma or papilloma) or high risk breast lesion(Atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical papilloma).
Previous breast cancer and /or radiation in the operated breast.
Implants in the operated breast.
Subareolar location (cancer is directly and completely under the nipple/areolar complex) of breast abnormality.
Breast cancer
Inflammatory breast cancer
Current diagnosis of invasive or inflammatory breast carcinoma
Presence of breast implants
Scheduled for intraoperative radiation of breast or chest wall
Undergoing autologous breast reconstruction
Inclusion Criteria:\n\n          -  • Patient has a non-palpable breast lesion that requires excision\n\n               -  Lesion depth ? 3 cm from the skin surface in the supine position\n\n               -  Patient is scheduled for excision or BCT at a participating institution\n\n               -  Patient is between the ages of 18 and 90 years\n\n               -  Patient is female\n\n               -  Patient is willing and able to comply with all study procedures and be available\n                  to follow-up for the duration of the study\n\n               -  For lesions requiring multiple reflectors for localization, they must allow for\n                  reflectors to be placed ? 1cm from one another relative to the coronal plane\n                  Subject Exclusion Criteria\n\n        An individual who meets any of the following criteria will be excluded from participation\n        in this study:\n\n          -  Patient had a previous ipsilateral breast cancer\n\n          -  Patient has multicentric breast cancer\n\n          -  Patient has Stage IV breast cancer\n\n          -  Patient has been treated with neoadjuvant chemotherapy\n\n          -  Patient is pregnant or lactating\n\n        Exclusion Criteria:
Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
Histologically confirmed invasive triple negative Breast Cancer
Patients with inflammatory breast carcinoma
Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapy
Patients with inflammatory breast cancer
Clinically detected or palpable disease prior to biopsy in either breast or ipsilateral axilla
Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS)
Metastatic or locoregionally recurrent HER2-negative breast cancer; resectable disease allowed
Histologic or cytologic confirmation of invasive breast cancer that is HER2-negative by standard clinical criteria
Bilateral or inflammatory breast cancer
Patient has metastatic breast cancer that is not suitable for surgery or radiation therapy for local disease control at the time of screening.
Previously untreated breast cancer determined by a core needle biopsy showing invasive ductal carcinoma or invasive lobular carcinoma
A prior, unrelated, breast cancer is allowed
Patients planned for pre-operative chemotherapy or those with known metastatic breast cancer
Inflammatory breast cancer
Histologic confirmation of invasive adenocarcinoma originating in the breast
Documentation of HER2 negative breast cancer at the time of protocol registration; (Note: HER2 negativity is defined as 0 or 1+ by immunohistochemistry OR nonamplified or equivocal by fluorescence in situ hybridization [FISH]; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)
Males or females with advanced (locoregionally recurrent or metatstatic) breast cancer not amenable to curative therapy
Patient has confirmed HER2-negative advanced breast cancer (aBC)
Inflammatory breast cancer or tumor with deep adherence or cutaneous invasion
Breast cancer in BRCA1 or BRCA2 positive ovarian cancer patients.
Diagnosis of inflammatory breast cancer
For the dose expansion cohort, patients with triple-negative breast cancer may not be BRCA1/2 germline mutation carriers
Participants must have histologically confirmed invasive breast cancer; all histologic subtypes are eligible
Patients must have the clinical diagnosis of inflammatory breast cancer
Patients may have bilateral breast cancer so long as one breast meets criteria for inflammatory breast cancer, and neither breast cancer has received prior therapy
Histologically confirmed invasive breast cancer
Evidence of T4 disease (e.g., involvement of the chest wall, skin, dermal lymphatics, or inflammatory breast cancer)
Documented mutation of tumor protein 53 (TP53), breast cancer (BRCA)1, BRCA2, or other hereditary cancer syndromes
Prior breast or chest radiotherapy for any indication
Patients with prior history of stage I-III breast cancer currently without evidence of metastatic disease are eligible if can tolerate further chemotherapy, patients with newly diagnosed synchronous bilateral breast cancers are also eligible if at least one tumor is triple negative (response will be assessed in both breasts if invasive cancer is present in both)
No prior chemotherapy for this primary breast cancer
Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer
Locally recurrent breast cancer
Study participants must be cT1c - cT4a-d any N, M0; any T is allowed if node positive (biopsy proven and HER2 positive) including no primary invasive cancer or only ductal breast carcinoma in situ (DCIS); metastatic workup is not required
Breast tumor must be >= 1.5 cm in maximum diameter by clinical or any radiologic measurement, if node negative; if node is positive by biopsy, study participant will be eligible regardless of the size of the breast primary; in case of inflammatory breast cancer, the extent of inflammation/erythema can be used as measurable lesion
Multifocal or multicentric breast cancer is allowed if all the lesions are biopsied and are HER2 positive; largest lesion will be assigned the target lesion
Prior radiation therapy for breast cancer
Histological confirmation of adenocarcinoma of the breast
Candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon
Patients with core breast biopsy that, on pathology review, demonstrates invasive breast cancer and are determined to need surgical excision of the lesion; all subtypes of invasive breast cancer will be enrolled; core biopsy specimens of enrolled patients will be stained for RET by immunohistochemistry and scored, however, patients will not be excluded according to RET expression
Subject has hormone-receptor positive metastatic breast cancer with disease progression following antiestrogen therapy
Subject has received more than 1 prior line of chemotherapy treatment for metastatic breast cancer
Pathologic documentation of invasive breast cancer by biopsy (fine needle aspiration [FNA] alone is not adequate)
Patients with a prior history of contra-lateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer within the last 5 years
Ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS) or breast conserving treatment and hormonal therapy for DCIS or invasive breast cancer
Paget’s disease of the breast
Prior history of DCIS or invasive breast cancer
Synchronous bilateral invasive or non-invasive breast cancer
All patients must have recurrent or metastatic HER2-positive breast cancer; diagnosed by biopsy
Patients with inflammatory breast cancer
Subject has inflammatory breast cancer
Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes
Inflammatory breast cancer
Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer; (comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer)
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy
FNA alone to diagnose the breast cancer
Synchronous bilateral invasive breast cancer
Synchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] are eligible)
Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)
Patients must not have received any prior treatment of any kind to treat the current breast cancer – including chemotherapy or endocrine therapy; in addition, any history of prior irradiation to the ipsilateral breast is excluded
No prior surgical excision in the index breast for current DCIS diagnosis of DCIS
Patients have histological confirmation of invasive breast carcinoma
Known invasive breast cancer of any type
Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
Patients who have received prior lapatinib for metastatic breast cancer will be excluded
Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed\r\n* Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant; (NOTE: the Oncotype DX testing must be completed on the largest lesion)\r\n* Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants (NOTE: Oncotype DX testing should be completed on all tumors and the determination for eligibility should be made on the highest recurrence score)\r\n* Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: the Oncotype DX testing should be completed on both tumors and the tumor with the highest recurrence score should be used)
Patients must not have inflammatory breast cancer and must not have metastatic disease
Patients with a prior diagnosis of contralateral ductal carcinoma in situ (DCIS) are eligible if they underwent a mastectomy or lumpectomy with whole breast radiation; prior partial breast irradiation, including brachytherapy, is not allowed; patients with a prior diagnosis of ipsilateral DCIS or invasive breast cancer who received radiation to that breast are not eligible
Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation); patients must have clear margins from both invasive breast cancer and DCIS (as per local institutional guidelines); lobular carcinoma in situ (LCIS) at the margins is allowed
Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration
Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.
Participants with prior mediastinal or thoracic radiotherapy. Prior tangential RT to prior breast cancer is acceptable.
Breast cancer must be HER2-negative.
Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.
HER2 positive breast cancer
Active inflammatory breast cancer
diagnosis of HR+, HER2+ breast cancer (BC)
Phase 1 patients (breast or ovarian cancer)
Phase 2 patients (breast or ovarian cancer)
Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
Triple Negative Breast Cancer
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer
Patient with inflammatory breast cancer at screening
Metastatic Breast Cancer: Human Epidermal Growth Factor Receptor 2 - negative (HER2(-)) recurrent Metastatic Breast Cancer:
Currently receiving chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer
Subject has inflammatory breast cancer
Have not previously received therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer
Has pathologically documented breast cancer that:
Centrally assessed Ki-67, pRB, and Cyclin D1 status assessed preferably on post-neoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion or core biopsy. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable.
Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.
Carcinoma in situ of the breast
definitively treated, stage I/II ER+ breast cancer
Proven diagnosis of metastatic breast cancer (MBC).
Exceptions are breast cancer in the other breast.
Uncommon or rare subtypes of breast cancer.
Carcinoma in situ of the breast
Completely resected unilateral or bilateral primary carcinoma of the breast
Note that patients with (i) non-invasive breast cancer (DCIS) alone, (ii) incidental (microscopic) nodal cancer without a primary tumor (pN1mi), or (iii) metastatic disease are excluded.
Clinical evidence of distant metastases per practice guidelines for breast cancer;
Inflammatory breast cancer or tumor with deep adherence or cutaneous invasion;
Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for ER+ breast cancer
Women who agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer to confirm the ER+ (>= 10% nuclear staining) and HER2 negative status
Women (?18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
Subjects with Inflammatory breast cancer.
Part B: Breast Cancer
Cohort 1: Participants must have triple negative breast cancer.
Confirmed diagnosis of HR-negative, HER2-negative (locally recurrent or metastatic TNBC) breast cancer
Carcinoma in situ of the breast
Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an AI, or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer
The subject has AR+ breast cancer
The subject has a history of a non-breast cancer malignancy with the following exceptions:
Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
Documented Breast Cancer Gene (BRCA) germline mutation testing.
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
Histological or cytological confirmation of ER+ and/or PR+ breast cancer
Patients who received more than one chemotherapy line for advanced breast cancer.
Patients who wish to breast-feed during treatment
Inflammatory breast cancer
triple-negative adenocarcinoma of the breast
Histological confirmation of breast carcinoma
Metastatic breast cancer patients currently on hormonal therapy as first- or second-line are not permitted
Patient with inflammatory breast cancer at screening .
Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
Confirmed diagnosis of ER positive breast cancer
No treatment for current primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, immunotherapy, investigational therapy or surgery; previous treatment for breast and/or ovarian cancer with chemotherapy, endocrine therapy, surgery and radiation are allowed if >= 3 years prior to current diagnosis and there is no clinical evidence of metastatic disease
Patient has HER2-negative breast cancer
Patients who currently have inflammatory breast cancer at screening.
Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ? 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
Have inflammatory breast cancer
Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
Histologically confirmed invasive breast cancer with a primary tumor size of greater than (>) 2 cm
HER2-positive breast cancer
Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer
Participants with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer
Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
Subjects with HER-2 expressing stage I – III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy
12 patients with breast cancer for whom 5 FU chemotherapy is the standard treatment
Confirmed diagnosis of HR+/HER2- breast cancer
Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer
If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision
No prior history of non-breast invasive malignancies in the past 1 year
Patient is not a candidate for breast conservation
Confirmed diagnosis of ER positive breast cancer
Subjects with more than 2 events of disease progression after the development of metastatic breast cancer.
Patients with biopsy-confirmed breast cancer
History of any prior (ipsi- and/or contralateral) invasive breast cancer
Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, stage I-III at diagnosis (AJCC 6th edition) based on initial evaluation by clinical examination and/or breast imaging. NOTE: Patients with ER+ and/or PR+ may enroll ONLY if they are known carriers of a deleterious mutation in BRCA1 or BRCA2. Patients with HER2+ tumors may not enroll regardless of BRCA status.
Miller-Payne response in the breast of 0-25.
Alternatively, if Miller-Payne or RCB grading is not available, the patient will be eligible if the pathology report indicates that the area of residual invasive disease in the breast measures at least 2 cm following preoperative therapy. The presence of DCIS without invasion does not qualify as residual disease in the breast.
Metastatic triple negative breast cancer (TNBC)
Concomitant active malignancy other than ER+ breast cancer.
Newly diagnosed (cohort 2) stage IV metastatic ER+HER2- breast cancer histologically proven per current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; allow up to 30 days prior use of endocrine therapy +/- CDK4/6 inhibitors for treatment of metastatic ER+ breast cancer
Pathologically confirmed invasive breast cancer by core needle biopsy
Clinical T2-T4c, any N, M0 invasive breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node;\r\n* The extent of disease is a solitary lesion where the lesion: \r\n** is palpable\r\n** size can be measured bi-dimensionally by tape, ruler or caliper technique, and\r\n** largest tumor diameter is at least 2.0 cm (that is considered measurable by the World Health Organization[WHO] criteria)\r\n* Note:\r\n** Patients with contralateral invasive breast cancer are not eligible\r\n** Patients with contralateral ductal carcinoma in situ (DCIS) are eligible\r\n** Patients with multifocal/multi-centric invasive breast cancer are not eligible; additional foci of DCIS in the same breast are acceptable
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)
An excisional biopsy of this breast cancer
History of invasive breast cancer prior to the current diagnosis
Patients must have histologically confirmed invasive breast cancer with a primary tumor >= 2 cm in greatest dimension as measured by clinical or radiologic examination
Willing to undergo breast core biopsies as required by the study protocol
Patients with recurrent breast cancer; patients with contralateral second primary breast cancers are eligible
Patients with metastatic breast cancer
Patients with documented HER2-positive metastatic disease are not eligible, even if their primary breast cancer was HER2-negative
Have a diagnosis of HR+, HER2- breast cancer.
Participants with radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or metastatic breast cancer
Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
The cancer enhances on breast MRI imaging
History of ipsilateral breast cancer
Prior history of ipsilateral breast cancer
Paget’s disease of the breast
Participants must have histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced; histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
For patients with bilateral or multifocal/multicentric breast cancers, one of the following criteria must be met to enroll: (1) each cancer individually meets criteria for enrollment (only ONE tumor has to undergo central confirmation for HER2), OR (2) at least one tumor meets eligibility (per tumor size/nodes/subtype outlined above) and the other foci in the ipsilateral or contralateral breast are also HER2-positive but are too small for enrollment (e.g., a patient is eligible if a cancer is T2N0 and HER2-positive in one breast, but the contralateral breast has a T1b HER2+ cancer that isn’t eligible on its own, OR, (3) at least one tumor meets eligibility and the other foci in the ipsilateral or contralateral breast are HER2-negative and do not meet criteria for adjuvant chemotherapy per provider discretion (e.g. if a patient has a HER2-positive tumor meeting eligibility but also has a second, HER2-negative, small, node-negative, ER+, low grade cancer present, she is still eligible for enrollment); however, in the specific case that a second breast cancer is stage III and HER2-negative, that patient is excluded (because the second cancer is high-risk and likely will require non-HER2-directed therapy)
=< 90 days from the patient’s most recent breast surgery for this breast cancer
History of previous invasive breast cancer =< 5 years\r\n* NOTE: history of DCIS, lobular carcinoma in situ (LCIS) is allowed
Subject is female ? 18 years of age (at the time of signing the informed consent form) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
Have been diagnosed with noninvasive or invasive (stage 1, 2, or 3A) breast cancer, colon cancer, lymphoma, or ovarian cancer
Inflammatory/inoperable breast cancer.
Prior endocrine therapy for breast cancer.
History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiotherapy or contralateral invasive breast cancer at any time.
Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
Normal mammogram of the contralateral breast within the past 12 months, defined as no new suspicious calcifications or other abnormal findings warranting a breast biopsy
History of histologically-confirmed bilateral breast cancer
Evidence of metastatic breast cancer
Women must agree not to breast feed
Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed:\r\n* Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant\r\n* Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants\r\n* Synchronous bilateral disease is defined as invasive breast cancer in both breasts, diagnosed within 30 days of each other
Patients must not have inflammatory breast cancer (T4d) and must not have metastatic breast cancer (stage IV disease)
Male and female participants with locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer. Participants with inflammatory breast cancer must be able to have a core needle biopsy
HER2-positive breast cancer confirmed by a central laboratory
Have a diagnosis of HR+, HER2- breast cancer
Men with metastatic or unresectable breast cancer are eligible
PHASE II: Participants must have histologically confirmed invasive breast cancer; all histologic subtypes are eligible
PHASE II: Patients must have the clinical diagnosis of inflammatory breast cancer as evidenced by the onset of signs and symptoms noted below within a 6 month time-period:\r\n* Erythema of the breast\r\n* Edema of the skin of the breast\r\n* Enlargement of the breast
More than 2 prior lines of chemotherapy for metastatic breast cancer.
Carcinoma in situ of the cervix or breast
HER2+ metastatic breast cancer, documented as HER2+ by FISH and/or 3+ staining by immunohistochemistry.
Breast > 800 grams or < 100 grams in predicted weight; “breast” includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass; the sum total must be > 100 g and < 800 g
Surgeon’s opinion at the time of surgery that the subject’s well-being (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems) would be compromised; if the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care
HER2-positive breast cancer
History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma
History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study
Patients must have had exposure to at least 1 and no more than 3 prior chemotherapy regimens for the treatment of metastatic breast cancer
Residual invasive disease in the breast measuring at least 2 cm. The presence of DCIS without invasion does not qualify as residual disease in the breast.
BREAST RADIOTHERAPY:
Partial breast irradiation must be scheduled to begin less than 71 days from the last breast surgical procedure
Patients with squamous or sarcomas of the breast
Patients with breast implants are excluded.
Patients have histological confirmation of breast carcinoma
Patients who have received a previous HER2 breast cancer vaccine
Participants must have histologically confirmed HER2+ (3+ by immunohistochemistry and/or FISH ratio >= 2.0) invasive breast cancer; central confirmation of HER2 status is not required
Histologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast; NOTE: women with history of breast cancer, radiation, or plastic surgery to the contralateral breast, or concurrent bilateral breast cancer, will not participate in the FNA portion of the study
Patients with synchronous bilateral breast cancers are eligible if at least one of the tumors is HER2-positive
=< 90 days between the planned treatment start date and the patient’s most recent breast surgery for this breast cancer
Patients with a history of previous invasive breast cancer
Patients with hormone receptor +/- and HER2 +/- breast cancer are eligible
If a patient has HER2-positive breast cancer, herceptin and pertuzumab will be given along with taxane therapy
Any stage invasive breast cancer provided the primary breast tumor size is >= 1 cm
Histologically confirmed invasive cancer of the breast.
Prior treatment for the currently diagnosed breast cancer
Participants must have histologically confirmed invasive breast cancer; all histologic subtypes are eligible
Patients must have the clinical diagnosis of inflammatory breast cancer as evidenced by the onset of all signs and symptoms noted below within a 6 month time-period:\r\n* Erythema of the breast\r\n* Edema of the skin of the breast\r\n* Enlargement of the breast
Prior therapy for the treatment of breast cancer is not allowed
Locally recurrent resectable breast cancer
HER2-positive breast cancer
History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
Breast cancer patients must be currently on adjuvant aromatase inhibitors
No prior treatment for metastatic breast cancer
Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
Family history of familial cancer syndromes (leukemia, breast, ovarian, colorectal, etc.)
Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study
Pathologically confirmed diagnosis of breast cancer with documented progressive disease
Participants must have histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced; histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
Prior taxane therapy for metastatic breast cancer.
Subjects with advanced stage breast cancer
Subjects with prior history of cancer in the ILT treated breast
Subjects with recurrent breast cancer
Undergoing concurrent neoadjuvant therapies for breast cancer
Participants must have histologically confirmed invasive breast cancer confined to the breast and regional lymphatics (supraclavicular, axillary, internal mammary lymph nodes)
Participants must have completed definitive breast surgery (mastectomy or breast-conserving) +/- reconstructive surgery with referral for definitive chest wall radiation therapy; patients with breast reconstruction are eligible if it determined by the referring or treating radiation oncologist that plan would be suboptimal without manipulation of breast implants; for patients without reconstruction, they must meet eligibility by having unfavorable cardiac anatomy defined as >= 5% of the heart receives >= 20 Gy and/or left anterior descending (LAD) receives >= 20 Gy with conventional planning; participants do not need to have measurable disease; most patients will not have measurable disease at the time of treatment
Histologically confirmed Stage I to III invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.
Prior allergic reaction to trastuzumab for the treatment of metastatic breast cancer
Patients with synchronous contralateral invasive breast cancer are excluded
Patients with multicentric gross disease defined as tumors in different quadrants of the breast or tumor separated by at least 4 cm or other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy or biopsy
Any previously treated contralateral invasive breast carcinoma or synchronous contralateral breast carcinoma
Patients who have received agents that modulate or downregulate the estrogen receptor for breast cancer prevention (e.g. tamoxifen, raloxifene, fulvestrant) or bone health (raloxifene) are eligible if they were on treatment for at least 6 months, did not have a diagnosis of breast cancer on the medication, and have discontinued the agents 6 months prior to study registration
The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ
For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS
If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
History of prior invasive or in situ cancer in either breast
Current diagnosis of bilateral breast cancer
Recurrent breast cancer
Breast cancer with metastasis to skeletal sites only
Patients who have received prior chemotherapy for their original breast cancer treatment are still eligible
Carcinoma in situ of the breast
Been treated for early breast cancer with standard of care duration of trastuzumab.
Current carcinoma of the breast
Carcinoma in situ of the breast
Advanced breast cancer with positive BRCA1 or BRCA2 status
Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines that is confirmed by a Sponsor-designated central laboratory
History of breast cancer (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the current diagnosis
Have histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required at diagnosis
Evidence of metastatic breast cancer following a standard tumor staging work-up
Evidence of inflammatory breast cancer
Subjects unfit for breast and/or axillary surgery (complete fixation of tumor, skin infiltration, erythema of the breast, and/or ulceration)
Breast cancer: Patients with Her-2 negative breast cancer after anthracycline and taxane based chemotherapy.
Part 2 includes target expressing NSCLC, ovarian or breast cancer patients
ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or
Prior endocrine therapy for any histologically-confirmed cancer is not allowed; prior endocrine therapy that was administered >= 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed
Any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides letrozole [10-21 days] before surgical resection of the primary breast tumor)
Patients with histologically or cytologically confirmed locally advanced breast cancer that is refractory to chemotherapy or other therapeutic agents or with a history of breast cancer with new evidence of a local recurrence (defined as a chest wall or breast recurrence and/or nodal recurrence); the diagnosis will be made based on clinical and pathologic features
Clinical T2-T4c, any N, M0 invasive ER+ (Allred score of 6-8) and HER2 negative (0 or 1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] negative for amplification) breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node; \r\n* Note: if the patient has invasive or ductal carcinoma in situ (DCIS) in the contralateral breast the patient is not eligible for this study
Invasive cancer or DCIS in the contralateral breast
Evidence of inflammatory cancer (clinical presentation of skin erythema involving more than one third of the breast or pathological evidence of dermal lymphatic involvement)
Previous excisional biopsy of the breast cancer
Age > 70 years with invasive breast cancer clinical size =< 3 cm OR\r\nAge 50 - 70 years with invasive breast cancer clinical size =< 1.5 cm OR\r\nAge >= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility)
Cancer in a patient with a known inherited susceptibility mutation in breast cancer (BRCA)1 or BRCA2
Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants
Any prior breast cancer
With advanced breast cancer whose disease was refractory to previous letrozole or anastrozole
Patients must have histologically proven breast cancer with metastatic disease to the brain
Patients who are receiving concomitant systemic therapy for breast cancer
Patients with metastatic breast cancer
Cohort 1: Has triple negative breast cancer, is considered for cohort 1 participation, and received prior anthracycline therapy
Pathologically confirmed invasive cancer of the breast
Candidate for curative breast cancer surgery (Cohort 1 or 2)
Carcinoma in situ of the breast.
Diagnosis of invasive adenocarcinoma of the breast made by core needle biopsy
Synchronous bilateral breast cancer (invasive or ductal carcinoma in situ [DCIS])
Treatment with biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
Prior history of invasive breast cancer (patients with a history of DCIS or lobular carcinoma in situ [LCIS] are eligible)
Patient has T1c-T3, any N, M0, operable breast cancer
Any prior treatment for the current primary invasive breast cancer
Bilateral invasive breast cancer
Multicentric breast cancer
Adenocarcinoma of the breast.
Primary breast cancer that is suitable for baseline core biopsy.
Bilateral invasive breast cancer.
Inflammatory breast cancer.
Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
Recurrent ipsilateral breast cancer
Breast cancer eligible for primary surgery
Any prior treatment for primary invasive breast cancer
Bilateral invasive, multicentric, or metastatic breast cancer
Breast cancer
Breast cancer
Inflammatory breast cancer
Histologically verified breast cancer with distant metastases (metastatic breast cancer)
Concurrent anti-cancer treatment, except anti-hormonal therapy for subjects with hormone receptor positive breast cancer
Prior or concomitant treatment for advanced breast cancer.
For subjects with breast cancer:
Breast cancer in BRCA1 or BRACA2 positive ovarian cancer patients
No current evidence of breast cancer
Recurrent breast cancer or other malignancy
Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion
Part 2 includes advanced triple negative breast cancer patients.
Pathologically confirmed diagnosis of breast cancer (central confirmation is not required)
Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease o Patients with breast cancer overexpressing HER2 are not eligible.
Patients with multiple foci of invasive cancer in the same breast are eligible if any single lesion meets the above size criteria and all sampled lesions are histologically similar (whether radiographically detected lesions separate from the target lesion are sampled for histologic evaluation is left to the discretion of the treating physicians); the presence of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) in either breast will not render a patient ineligible; patients with a small focus of invasive cancer detected the contralateral breast (clinical T1N0) are eligible, however only the histologic response in the breast containing the target lesions will be considered in determining the patient’s pathologic response
Advanced (T1N1-4/T2-3 N any) invasive cancer in the contralateral breast
Patients must have histologically or cytologically confirmed breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d’orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis
For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines
Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty
Pre-operative treatment with induction chemotherapy for breast cancer
Treated CIS of the breast or cervix
ER+/HER2+ breast, ovarian, cervical, endometrial cancer, or other solid cancers, resistance to standard therapies with a PIK3CA gene mutation (Part C), AKT1 gene mutation (Part D) or a dysregulatory aberration on the PIK/AKT pathway (Part D), advanced or metastatic ER+ positive breast cancer that has an AKT1 gene mutation (Part E) or advanced or metastatic ER+ positive breast cancer that has a PTEN gene mutation (Part F).
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral ductal breast carcinoma in situ (DCIS) treated with radiation therapy; (Patients with synchronous or previous ipsilateral lobular breast carcinoma in situ [LCIS] are eligible)
Synchronous or previous contralateral invasive breast cancer; (patients with contralateral DCIS not treated with radiation are eligible)
Patients treated with neoadjuvant chemo or endocrine therapy for breast cancer
Has received prior capecitabine treatment for advanced breast cancer
Has received more than 1 prior antiangiogenic agent for breast cancer
Inclusion Criteria - Phase 1 (Cohort A):\n\n          -  Female patient ? 18 years\n\n          -  Patient must be postmenopausal, verified by 1 of the following:\n\n               -  Bilateral surgical oophorectomy\n\n               -  No spontaneous menses > 1 year\n\n               -  No menses for < 1 year with FSH and estradiol levels in postmenopausal range\n\n          -  Postmenopausal women with primary invasive breast cancer, histologically confirmed by\n             core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone\n             (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10%\n             or more nuclear staining of the invasive component of the tumor\n\n          -  Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or\n             locally relapsed, unresectable disease\n\n          -  Measurable or evaluable disease according to RECIST criteria (see appendix VII)\n\n          -  Both HER2-positive and HER2-negative disease (as defined by IHC or by fluorescence in\n             situ hybridization [FISH]). HER2+ must have had prior treatment with trastuzumab\n             and/or lapatinib.\n\n          -  ECOG performance status 0-2 (see appendix VI)\n\n          -  Patients are suitable candidates for treatment with anastrozole (patients may have had\n             any prior endocrine therapy or prior chemotherapy for treatment of their disease,\n             either as adjuvant therapy, or as treatment for advanced disease). There is no\n             restriction on the number of prior regimens in the phase I cohort A.\n\n          -  Patient is accessible and willing to comply with treatment and follow-up\n\n          -  Patient is willing to provide written informed consent prior to the performance of any\n             study-related procedures\n\n          -  Required laboratory values\n\n               -  Absolute neutrophil count ? to 1.5 x 10^9/L\n\n               -  Hemoglobin ? to 9.0 g/dL\n\n               -  Platelet count ? to 100 x 10^9/L\n\n               -  Creatinine ? 1.5 mg/dL\n\n               -  Total bilirubin ? 1.0 x upper limit of normal (ULN)\n\n               -  Alkaline phosphatase and AST/ALT within protocol parameters. In determining\n                  eligibility, the more abnormal of the two values (AST or ALT) should be used.\n\n        Inclusion Criteria - Phase 2 (Cohort B):\n\n          -  Female patient ? 18 years\n\n          -  Patient must be postmenopausal, verified by 1 of the following:\n\n               -  Bilateral surgical oophorectomy\n\n               -  No spontaneous menses ? 1 year\n\n               -  No menses for < 1 year with FSH and estradiol levels in postmenopausal range\n\n          -  Postmenopausal women with primary invasive breast cancer, histologically confirmed by\n             core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone\n             (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10%\n             or more nuclear staining of the invasive component of the tumor. Patients may have\n             bilateral or multifocal invasive breast cancers. The patient may have concurrent DCIS\n             in either breast but the DCIS will not be measured as part of the study endpoints.\n\n          -  Tumor size ? 2 cm\n\n          -  Tumor measurable either by clinical examination, mammography, MRI, or ultrasound\n\n          -  HER2-negative disease (as defined by fluorescence in situ hybridization [FISH] or by\n             IHC)\n\n          -  ECOG performance status 0-1 (see Appendix VI)\n\n          -  Patient is accessible and willing to comply with treatment and follow-up\n\n          -  Patient is willing to provide written informed consent prior to the performance of any\n             study-related procedures\n\n          -  Required laboratory values\n\n               -  Absolute neutrophil count ? 1.5 x 10^9/L\n\n               -  Hemoglobin ? 9.0 g/dL\n\n               -  Platelet count ? 70 x 10^9/L\n\n               -  Creatinine ? 1.5 mg/dL\n\n          -  Total bilirubin ? 1.5 x upper limit of normal (ULN)\n\n          -  Alkaline phosphatase and AST/ALT ? 1.5 x upper limit of normal (ULN)\n\n        Exclusion Criteria - Phase 1 (Cohort A):\n\n          -  Concurrent therapy with any other non-protocol anti-cancer therapy\n\n               -  Any agent with estrogenic or putatively estrogenic properties, including herbal\n                  preparations, must be stopped at least one week prior to registration.\n\n               -  Ongoing, chronic administration of bisphosphonate therapy is allowed so long as\n                  such treatment was ongoing at the time of study entry.\n\n          -  Current therapy with hormone replacement therapy, or any hormonal agent such as\n             raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be\n             stopped prior to randomization)\n\n          -  Presence of neuropathy ? grade 2 (NCI-CTC version 3.0) at baseline\n\n          -  History of any other malignancy within the past 5 years, with the exception of\n             non-melanoma skin cancer or carcinoma-in-situ of the cervix\n\n          -  Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100],\n             history of myocardial infarction or stroke within 6 months, unstable angina), New York\n             Heart Association (NYHA) Grade II or greater congestive heart failure, or serious\n             cardiac arrhythmia requiring medication\n\n          -  Active, uncontrolled infection requiring parenteral antimicrobials\n\n          -  A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their\n             excipients\n\n          -  Evidence of bleeding diathesis or coagulopathy.\n\n          -  Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a\n             24 hr period.\n\n          -  Since AZD0530 is a substrate and inhibitor of CYP3A4, patients requiring medication\n             with drugs listed in Appendix XI should be excluded from study.\n\n          -  Any evidence of severe or uncontrolled systemic medical or psychiatric conditions\n             (e.g. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse,\n             parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac\n             conditions which make it undesirable for the patient to participate in the study or\n             which could jeopardize compliance with the protocol\n\n          -  Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by\n             pulse oximetry, interstitial pulmonary infiltrates on high resolution CT scan prior to\n             study entry and/or symptomatic pulmonary (pleural or parenchymal) metastasis.\n\n        Exclusion Criteria - Phase 2 (Cohort B):\n\n          -  Prior chemotherapy, endocrine therapy or radiotherapy for the presenting breast\n             cancer. Prior incidence and treatment of contralateral invasive or non-invasive breast\n             cancer is not an exclusion criterion.\n\n          -  Inflammatory breast cancer, clinically defined as the presence of erythema or\n             induration involving one-third or more of the breast, or pathologically defined as\n             dermal lymphatic invasion\n\n          -  Prior excisional biopsy or complete resection of the primary invasive tumor (prior\n             sentinel node biopsy allowed)\n\n          -  Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer\n\n          -  Distant metastasis is an exclusion criterion - Isolated ipsilateral supraclavicular\n             node involvement and/or direct invasion of the primary tumor into skin is allowed\n\n          -  Concurrent therapy with any other non-protocol anti-cancer therapy\n\n          -  Any agent with estrogenic or putatively estrogenic properties, including herbal\n             preparations, must be stopped at least one week prior to registration\n\n          -  Current therapy with hormone replacement therapy, or any hormonal agent such as\n             raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be\n             stopped for one week prior to randomization)\n\n          -  Presence of neuropathy ? grade 2 (NCI-CTC AE version 3.0) at baseline\n\n          -  History of any other malignancy within the past 5 years, with the exception of\n             non-melanoma skin cancer or carcinoma-in-situ of the cervix\n\n          -  Clinically significant cardiovascular disease (e.g. history of myocardial infarction\n             or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade\n             II or greater congestive heart failure, or serious cardiac arrhythmia requiring\n             medication\n\n          -  Active, uncontrolled infection requiring parenteral antimicrobials\n\n          -  A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their\n             excipients\n\n          -  Evidence of bleeding diathesis or coagulopathy\n\n          -  Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a\n             24 hr period.\n\n          -  AZD0530 is a substrate and inhibitor of CYP3A4. Since concurrent administration of\n             AZD0530 with other CYP3A4 substrates has been shown to be well tolerated, continuation\n             or initiation of medically indicated drugs that are substrates of CYP3A4 is permitted\n             at MD discretion. Drugs listed in Appendix XI that are known to strongly induce or\n             inhibit CYP3A4 activity should be discontinued prior to study entry and should not be\n             initiated during protocol treatment.\n\n          -  Any evidence of severe or uncontrolled systemic psychiatric or medical conditions (eg.\n             Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal\n             lung disease]) or current unstable or uncompensated respiratory or cardiac conditions\n             which make it undesirable for the patient to participate in the study or which could\n             jeopardize compliance with the protocol\n\n          -  Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by\n             pulse oximetry prior to study entry and/or symptomatic pulmonary (pleural or\n             parenchymal) disease.\n\n          -  Subjects unwilling or unable to undergo breast MRI as required by protocol will be\n             excluded from study
Patients with history of breast cancer greater than 5 years from initial diagnosis and are disease free are eligible for the study; patients with history of ductal carcinoma in situ (DCIS) are eligible if there were treated with surgery alone
Hormone-refractory metastatic breast cancer defined as disease progression within 6 months from starting most recent hormonal therapy
Early stage breast cancer (T1c-3, cN0-3, cM0)
Subjects with prior skin changes consistent with inflammatory breast carcinoma are eligible.
Breast carcinoma for medical reasons not being resected
Previous (required active treatment within 5 years) or concomitant malignancy except basal cell cancer, in situ carcinoma of the cervix, or contralateral breast cancer. Subjects with a prior contralateral breast malignancy can be included if they did not receive any chemotherapy.
Has a condition which may interfere with the hyperthermia portion of the trial such as: functioning cardiac pacemaker; metal plates, rods or prosthesis of the chest wall, breast reconstruction with implants, severe numbness and/or tingling of the chest wall or breast, skin grafts and/or flaps on the breast or chest wall.
Carcinoma in situ of the breast
Patient with inflammatory breast cancer
For the dose expansion cohort, patients with triple-negative breast cancer may not be breast cancer 1/2 (BRCA1/2) germline mutation carriers
No prior history of ipsilateral breast cancer (invasive disease or ductal breast carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
No history of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
Diagnosis of breast or gynecologic cancer, all types (examples are ductal carcinoma in situ [DCIS], lobular carcinoma in situ[LCIS], invasive breast, ovarian, endometrial, vulvar, cervical and vaginal)
Have a diagnosis of breast cancer and be chemotherapy naive; NOTE: prior methotrexate for non-cancerous conditions is allowed
History of invasive breast cancer
Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry [IHC]), and treated with curative intent\r\n* Note:\r\n** Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible\r\n** Patient with invasive breast cancer or synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) during pregnancy are eligible\r\n** Patients with breast cancer 1/2, early onset (BRCA1/2) mutations are eligible\r\n** Patients could have received neo/adjuvant chemotherapy, or other systemic therapy (e.g., neo/adjuvant human epidermal growth factor receptor 2 [HER2]-targeted therapy) according to institutional policy and patient’s desire
Post-menopausal patients at breast cancer (BC) diagnosis, as determined locally
Patients with current local, loco-regional relapse and/or distant metastatic breast cancer
Diagnosed with clinical or pathologic stage I?III invasive breast cancer with TX?T3 tumor
Recurrent breast cancer or history of prior breast radiation therapy
Breast cancer requiring bilateral breast/chest wall radiation therapy
Male breast cancer patients
Diagnosis of ductal carcinoma in situ (DCIS) or stage I, II, or III breast cancer
Diagnosis of other active malignancy; prior treated malignancies in addition to breast cancer are acceptable
Ever had a diagnosis of invasive or microinvasive breast cancer
Histologically confirmed stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
FOCUS GROUPS: \r\n* Breast cancer patient, stage 1,2, or 3,\r\n* Currently undergoing treatment with chemotherapy and/or radiation;\r\n* Food insecure;\r\n* Language spoken: English or Spanish
Diagnosed with metastatic breast cancer, caregiver to patient with metastatic breast cancer (MBC) who is enrolled in this study, or MBC provider
Men and women with recurrent or advanced breast cancer
Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis following the breast cancer (excluding non-melanoma skin cancer)
Pathologically confirmed breast cancer
Women at high risk of breast cancer due to one or more of the following:\r\n* Carry deleterious mutations in the breast cancer, early onset (BRCA)1, BRCA2, phosphatase and tensin homolog (PTEN), tumor protein p53 (TP53), serine/threonine kinase 11 (STK11), or cadherin-1 (CDH1) genes\r\n* Previous diagnosis of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH)\r\n* Lifetime risk of 20% or greater as calculated by the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool or the Tyrer-Cuzick International Breast Cancer Intervention Study (IBIS) Risk Assessment Tool
Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast)
Previous radiation in the operated breast
Implants in the operated breast
Inflammatory or metaplastic breast cancer
Prior ipsilateral breast cancer radiotherapy will be excluded; prior contralateral breast cancer therapy within 2 years will also be excluded
BREAST CANCER COHORT:
Are in breast cancer remission with no detectable disease present
Evidence of breast cancer recurrence or metastasis
Current recurrence of their breast cancer (BC) (local or distant)
No prior therapy for current breast cancer
Operable breast cancer\r\n* Patients who are planned to undergo neo-adjuvant chemotherapy are eligible as long as they consent to an additional breast biopsy following the dietary intervention immediately prior to starting chemotherapy
PATIENT: Confirmed medical diagnosis of breast or thoracic cancer regardless of stage and followed at DCC for management
Evidence of recurrent breast cancer at the time of enrollment
Females who have been diagnosed with breast cancer and currently taking toremifene
Patients with metastatic breast cancer
Women diagnosed with breast cancer stages 0-III within 18 months after completion of all planned surgery, radiation and or chemotherapy treatments
Metastatic breast cancer
New breast cancer diagnosis
History of recurrent breast cancer (with a prior history of chemotherapy)
Stage IV breast cancer diagnosis (metastases remote from the breast)
Prior genetic counseling or testing for hereditary breast/ovarian cancer
Recent diagnosis of breast cancer with pending surgery as primary treatment for breast cancer
Must not have had history of breast cancer, breast surgery, radiation to the chest wall
Lymphedema Group: > 3 months (mths) post-breast cancer treatment
No Lymphedema Group: > 3 mths post- breast cancer treatment
Having received chemotherapy as part of their primary therapy for breast cancer.
Diagnosed with any stage breast, GI, or lung cancer
Confirmed first diagnosis of stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer (MBC) (i.e., spread to distant organs), any time since diagnosis
Any medical treatment for breast cancer will be allowed
Participants who have been diagnosed with ductal carcinoma in-situ (DCIS) or invasive breast cancer and have been offered lumpectomy or mastectomy for surgical treatment will be considered for the study
Subjects will not have breast surgery as a portion of their breast cancer care
Subjects with breast implants or a history of prior breast implants
Patient must be an Asian American who has had a breast cancer diagnosis in the past 5 years
Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past 5 years will be included
Primary diagnosis of breast cancer (initial or recurrence) within the last two years
Recurrence of breast cancer
Participants must self-identify as female; thus only women with breast cancer will be invited to participate in this study
Phase I: Breast oncology team members at Massachusetts General Hospital (MGH) Cancer Center will be eligible if they are either physicians or nurse practitioners primarily involved in the care of breast cancer patients and with direct experience with metastatic breast cancer patients
Breast cancer survivors treated with chemotherapy with no evidence of disease with treatment completed at least six months prior to study participation with or without current endocrine therapy
Have a diagnosis of stage I-III female breast cancer or colorectal cancer within the past 5 years; bilateral or multiple primary breast cancers are permitted; individuals who have had more than one type of cancer (e.g., both breast and melanoma) are permitted as long as the breast (or colorectal) diagnosis meets the other criteria and primary treatment for any cancer is not ongoing
YOUNG BREAST CANCER SURVIVORS (YBCS): Breast cancer (Stages 0-III) diagnosis
YBCS: Breast cancer diagnosis age ? 45 years
Past cancer; patients will be excluded if they have ever been diagnosed with cancer (including ductal breast carcinoma in situ [DCIS]/lobular breast carcinoma in situ [LCIS]) prior to the breast cancer for which the present course of AIs is being prescribed; however, patients will be eligible if their have a history of: nonmetastatic, non-melanotomous skin cancer
Patients with metastatic breast cancer are not eligible to participate
Patients who have a diagnosis of breast cancer
Diagnosed with breast, GYN, GI, GU, or thoracic cancer
History of prior breast cancer surgery
Ambulatory outpatients with breast (including ductal carcinoma in situ [DCIS]) cancer
Breast cancer survivors
Have breast cancer stage 0-IIIA
No histological confirmation of breast cancer
Patients with a recurrent breast cancer diagnosis
Memorial Sloan Kettering Cancer Center (MSK) histologically confirmed early-stage operable breast cancer (patients with HER-2 negative or HER-2 positive breast cancer are eligible)
A diagnosis of local regional breast cancer (stage 0-IIIa)
Women who are known to be positive for the breast cancer (BRCA) mutation
Had a previous diagnosis of breast cancer (any type or stage) as confirmed by official medical records
Has been diagnosed with early-stage breast cancer
Women previously diagnosed with stage 0-IIIA breast cancer
Histologically confirmed stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
Patients should be followed in Stefanie Spielman Comprehensive Breast Center (SSCBC) High Risk Breast Clinic
PHASE I AIM 3.2: Malignant diagnosis in breast, gynecologic (GYN), genitourinary (GU) cancer at any stage
Have been diagnosed with stage 0-III breast cancer; bilateral or multiple primary breast cancers are permitted
Have a previous diagnosis of breast cancer
Breast cancer at age 50 or below
Bilateral breast cancer
Triple negative breast cancer
Have 2 or more blood relatives diagnosed with breast cancer
Have any blood relatives diagnosed with bilateral breast cancer
A first degree relative diagnosed with breast cancer below age 50
Have a known cancer gene mutation (such as breast cancer 1/2, early onset [BRCA 1/2])
Have any male relatives diagnosed with breast cancer
New diagnosis of breast cancer stage 1-2
Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
Histologically confirmed stage I, II or III breast cancer (if the patient has had more than one breast cancer diagnosis, then the most recent diagnosis)
Decided to have blood drawn for breast cancer, early onset gene (BRCA) 1/2 syndrome testing
In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer
Has been diagnosed with breast cancer, currently in remission or eradicated
Belongs to a breast cancer support group
Primary diagnosis of breast cancer within the last three years
Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/- chemotherapy, +/- radiotherapy
PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation)
Diagnosis of stage IV breast cancer or recurrent metastatic breast cancer
Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist
Previous radiation to the ipsilateral breast
Must have completed local therapy for their breast cancer
No local or distant recurrence of their breast cancer
Survivors of breast cancer that have not received either breast surgery or radiation therapy
Receiving treatment for another malignancy other than breast cancer
Diagnosis of metastatic breast cancer
Women with stage 1-3 breast cancer who are within first two rounds of chemotherapy OR women who have stage 4 breast cancer at initial diagnosis and are initiating first line chemotherapy; note: women with stage 4 breast cancer must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Diagnosis of recurrent breast cancer
Patients with metastatic breast cancer
Stage I-III gynecologic cancer (any site) or breast cancer
Prior treatment of gynecologic or breast cancer with chemotherapy
Prospective study: individuals will have pathologically confirmed breast cancer (stages I-III)
Metastatic breast or other cancer
History of breast cancer, ductal breast carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) (currently without evidence of malignant disease) OR a concern about taking estrogen for fear of breast cancer
Metastatic breast or other cancer
Have been diagnosed with non-metastatic breast cancer (stages 0-III)
Have completed curative treatment for breast cancer
Pathologically confirmed breast cancer
Women with a history of cancer, any stage, with breast or gynecologic cancer
Diagnosed with breast cancer
Patients who have been surgically treated for breast cancer more than 3 months; healing usually occurs within 3 months of surgical treatment for cancer
Are diagnosed with primary breast cancer (BC) (stages I-III)
Node-negative left breast cancer
Invasive or ductal carcinoma in situ (DCIS) breast cancer
Stage 0-IIIA breast cancer survivors and their partner
Male breast cancer survivors
Stage 1A – 2B breast cancer diagnosis
Pathologically confirmed HER2-positive breast cancer
Diagnosis of breast cancer
Intact breast (not surgically absent)
The patient must have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy
The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy)
Surgical margins are negative for invasive or non-invasive breast cancer
Unable to fit into the breast immobilization device due to breast size or other anatomical reason
Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer
Subjects with inflammatory breast cancer
Stage I and II breast cancer patients undergoing active radiation therapy
Patients eligible for the study will be newly-diagnosed female breast cancer patients with stage I-ll invasive breast cancer who are eligible for and considering either mastectomy or breast-conserving surgery (BCS) with radiation, and who may be eligible for adjuvant systemic treatment
Have a history of breast cancer
Patients must be women with histologically confirmed primary invasive carcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease (M0) or with histologically confirmed ductal carcinoma in situ (DCIS); if patient has undergone breast cancer surgery, she must have recovered from all side-effects of surgery
Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention
No prior chemotherapeutic treatment for any malignancy other than breast cancer
Histologically confirmed stage I-III colorectal or breast cancer who have undergone curative-intent complete surgical resection and completed all adjuvant cytotoxic chemotherapy and radiation (if indicated) at least 2 months prior to enrollment; breast cancer patients on hormonal therapy or trastuzumab only therapy and colorectal cancer patients on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in Cancer and Leukemia Group B [CALGB] 80702 receiving only celecoxib/placebo) are eligible
Diagnosis of HER2-positive breast cancer
Patients scheduled to undergo paclitaxel chemotherapy for breast cancer
Participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at UH GMC Seidman Cancer Center
Patient has diagnosis of biopsy-proven primary breast cancer or a diagnosis of pure ductal carcinoma in situ (DCIS) who will be undergoing intraoperative lymphatic mapping as part of their standard surgical plan
Pathologic documentation of breast cancer
History of a diagnosis of breast cancer
Breast/s reconstructed with implant in the area of previous radiation
Have been diagnosed with breast cancer
Breast cancer diagnosis within past 5 years
Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ
Subjects must be prescribed and scheduled for “conventional fractionated” RT without concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular nodes, axillary nodes, etc) as part of their prescribed radiation therapy are permitted; conventional fractionated radiation therapy regimens eligible for study are described below:\r\n* Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy\r\n* Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed = whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy\r\n* Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy\r\n* Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy\r\n* Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy\r\n* Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy\r\n* Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy\r\n* Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy
Subjects with bilateral breast cancer are not eligible
Previous radiation to the chest or breast
Subjects with breast reconstruction prior to RT
Presence of unhealed surgical wounds in chest or breast region and/or breast infection
Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
Completed treatment for breast cancer (except hormonal therapies) within 12 months.
Women with breast cancer who plan to undergo radiation therapy to the breast or chest wall
Women with inflammatory breast cancer as evidenced by clinical assessment
Women with breast cancer involving the skin
Women who have undergone prior radiotherapy to the chest wall and/or breast
Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per breast surgeon or medical oncologist
Have a diagnosis of breast cancer, any stage.
Patients who have not undergone autologous tissue breast reconstruction and intend to undergo implant only breast reconstruction
Patients with prior radiation to the breast/chest wall of the ipsilateral breast
Women initially diagnosed with breast cancer by histological tissue diagnosis in 2003 or later
Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer
Patients must not have symptoms or signs of benign or malignant breast disease (e.g., bloody or clear nipple discharge, breast lump) based on physician physical exam or self breast exam; patients with breast pain are eligible as long as other criteria are met
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not currently have breast enhancements (e.g., implants or injections)
Do not have a history of breast cancer
Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
Participants who have received breast radiation within 1 year prior to screening breast MRI
Diagnosed with breast cancer at age 45 or younger
Have at least 2 relatives with breast cancer on the same side of the family, one of which is =< 50 years of age
Have one male relative with breast cancer
Prior breast cancer or DCIS diagnosis
INCLUSION - PATIENT: Women presenting for breast cancer screening with either MRI or mammography: Group 1 will consist of women who present for screening breast MRI:\r\n* Asymptomatic for breast disease\r\n* Presenting for routine breast cancer screening with MRI
Recommendation for breast biopsy has been made
Have a first degree relative with a history of breast or colorectal cancer
Breast implants
Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months
Women and men with symptomatic breast lump (either by palpation or imaging) OR
Patients with known breast cancer
Patients with known diagnosis of breast cancer
Patients who have had a lumpectomy for breast cancer within 18 months prior to the study
Have one or more first or second degree relatives with breast cancer, with at least one under the age of 60
Have a prior diagnosis of T1 or T2 breast cancer diagnosed within the last 10 years
Have breast density assessed as >= 25% on a prior mammogram (Boyd 1995)
Women with bilateral breast implants or tram flap reconstruction
Women with a current mammographic or clinical breast exam mass which is suspicious for breast cancer (ACR class IV), and malignancy has not been ruled out
Inclusion Criteria:\n\n        A. Subjects whose most recent (within 18 months) prior mammogram interpreted as\n        heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast\n        Density D) breast tissue.\n\n        AND\n\n        B. Subjects who are asymptomatic and scheduled to undergo routine screening mammography.\n\n        OR\n\n        C. Subjects scheduled for image-guided needle biopsy as a result of findings obtained\n        during standard of care imaging modalities (mammography, ultrasound and/or MRI) performed\n        at the clinical site that participates in the study.\n\n        Exclusion Criteria:\n\n          1. Male by birth.\n\n          2. Individual is less than 40 and greater than 70 years old.\n\n          3. Contraindication to bilateral mammography or MRI.\n\n          4. Subjects who are unable to read, understand and execute the informed consent\n             procedure.\n\n          5. Subjects who have had mammography, ultrasound or MRI examination performed on the day\n             of the study prior to RI8 scan.\n\n          6. Subjects who are pre-menopausal and are between the 14th and 28th day after the start\n             of the menstrual cycle\n\n          7. Subjects who have significant existing breast trauma.\n\n          8. Subjects who have undergone lumpectomy/mastectomy.\n\n          9. Subjects who have undergone breast reduction or breast augmentation.\n\n         10. Subjects who have undergone any other type of breast surgery, including surgical\n             biopsy.\n\n         11. Subjects who have large breast scar / breast deformation\n\n         12. Subjects who have undergone a breast needle biopsy within the 6-week period prior to\n             their intended enrollment into the study.\n\n         13. Subjects who have a temperature > 100° F (37.8C) degrees on the day of the RI8\n             imaging.\n\n         14. Subjects who are pregnant or lactating.\n\n         15. Subjects with known Raynaud's Disease.\n\n         16. Subjects with known Mastitis.\n\n         17. Subjects diagnosed with epileptic seizures.\n\n         18. Subjects with weight > 135kg (~300 Lbs.).\n\n         19. Subjects who are claustrophobic or have physical limitations that do not allow them to\n             sit in the system chair for the required imaging session.\n\n         20. Subjects with implanted pacemaker/defibrillator, implanted venous access device\n             (portacath) or other implanted devices.\n\n         21. Subject with kidney failure\n\n         22. Subject with known allergy to gadolinium\n\n         23. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the\n             past two year)\n\n         24. Inmates (45 CFR 46.306) or mentally disabled individuals.\n\n         25. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the\n             purpose of planning cancer therapy).\n\n         26. Subjects currently participating in another investigational clinical study.\n\n         27. Subject scheduled for a biopsy due to suspicious symptomatic lump\n\n         28. Subjects who participated in the Validation Phase will not be able to participate in\n             the Testing Phase
2) Patients must have a diagnosis of breast cancer for which they must not have received or been scheduled for primary breast surgery at time of project intervention, and must be eligible for surgical resection (i.e. Stage I-III).
Patient must have no known breast cancer (DCIS or invasive cancer), not currently undergoing treatment for breast cancer, or planning surgery for a high risk lesion (atypical ductal breast hyperplasia [ADH], atypical lobular breast hyperplasia [ALH], lobular breast carcinoma in situ [LCIS], papilloma, radial scar)
Patient must not be taking chemoprevention for breast cancer
Patient must not be suspected of being at high-risk for breast cancer, as defined by the American Cancer Society (ACS) breast MR screening recommendations (lifetime risk of >= 20-25%)
BREAST CANCER SURVIVORS: Has histologically-confirmed, first-time breast cancer (stage I-IIIB);
BREAST CANCER SURVIVORS: Has no prior exposure to neurotoxic chemotherapy or radiation treatment;
BREAST CANCER SURVIVORS: Will be receiving either paclitaxel (Taxol or generic) either (a) weekly (~80-100mg/m^2) or (b) every other week (i.e., dose-dense) (~175 mg/m^2) Taxol for the treatment of breast cancer OR
BREAST CANCER SURVIVORS: Will be receiving an anthracycline and cyclophosphamide (AC) as a part of their initial treatment for breast cancer with plans to receive Taxol either weekly (~80-100mg/m^2) or every other week (i.e., dose-dense) (~175 mg/m^2);
Patients with breast implants
Women considered at increased risk for developing breast carcinoma (those with a lifetime risk of > 15% due to family history, genetic predisposition, prior radiation therapy to the chest, prior biopsy showing a high risk lesion, or personal history of breast cancer) that are being screened with breast MRI
Women with breast implants
Stage I-III female breast cancer (including inflammatory and newly diagnosed, or locally recurrent but not metastatic breast cancer being treated with curative intent)
Must be at increased risk for breast cancer, defined as at least one of the following four criteria:\r\n* Having had a prior biopsy demonstrating atypical hyperplasia, lobular carcinoma in situ (LCIS), or ductal carcinoma in situ (DCIS)\r\n* A Gail Model Risk of >= 1.66% over 5 years\r\n* A strong family history of breast and/or ovarian cancer which is defined as at least one of the following:\r\n** One first-degree relative with breast cancer before the age of 50 years\r\n** One first degree relative with bilateral breast cancer\r\n** Two or more first-degree relatives with breast cancer\r\n** One first degree relative and two or more second or third degree relatives with breast cancer\r\n** One first-degree relative with breast cancer and one or more relatives with ovarian cancer\r\n** Two second or third degree relatives with either breast cancer and one or more with ovarian cancer\r\n** One second or third degree relative with breast cancer and two or more with ovarian cancer\r\n** Three or more second or third degree relatives with breast cancer\r\n* Known breast cancer (BRCA)1 or BRCA2 mutation carrier providing that the woman has \r\n** Met with a genetic counselor to review genetic testing results, and \r\n** Has been offered the opportunity to undergo prophylactic mastectomy and oophorectomy
Mammograms must be read as not suspicious for breast cancer (American College of Rheumatology [ACR] class I-III); subjects with a class IV mammogram may be enrolled once they have been evaluated by a breast surgeon and there is no evidence of invasive malignancy
Bilateral breast implants or autologous breast flap reconstruction
Previous treatment for breast cancer including chemotherapy, endocrine therapy and radiotherapy; women with prior ductal breast carcinoma in situ (DCIS) who were treated with surgery only and whose treatment ended >= 2 years prior to enrollment are eligible for the trial
Less than 40 years if 5-year breast cancer Gail risk is >= 1.66%
Women with a previous history of invasive breast cancer or bilateral ductal carcinoma in situ (DCIS) or current untreated DCIS; women with a history of cancer within the last 3 years, except for non-melanoma skin cancer; women with unilateral DCIS (with or without radiation therapy) are eligible as long as they have an unaffected breast
Prior bilateral breast surgery (mastectomy, segmental mastectomy, or breast augmentation surgery including breast implants or breast reductions)
Invasive breast cancer; areas of microinvasion or suspicious for microinvasion on the core biopsy is allowed
History of prior breast cancer treated within the past two years; patients completing all breast cancer-specific treatment over two years prior to the current diagnosis are eligible
Women with bilateral breast implants or tram flap reconstruction
Women with current mammographic or clinical breast exam mass which is suspicious for breast cancer and malignancy has not been ruled out
FOCUS GROUP: No prior breast cancer, invasive or ductal breast carcinoma in situ (DCIS) (ever), no prior lobular breast carcinoma in situ (LCIS) diagnosis, no BRCA mutation carriers or genetic counseling visits
BETA/USABILITY TESTING: Utilizing the breast cancer surveillance consortium risk calculator, women will have high 5-year (> 1.66%) risk for breast cancer and high breast density (heterogeneously or extremely dense)
BETA/USABILITY TESTING AND THE TRIAL: Not able to speak and read English; cognitive impairment that precludes informed consent, history of LCIS (lobular carcinoma in situ), prior cancer diagnosis (including DCIS [ductal carcinoma in situ] and invasive breast cancer), known BRCA1/2 family mutation, or previous receipt of cancer genetic counseling
Histologically confirmed invasive breast cancer or Ductal Carcinoma In Situ (DCIS)
Prior history of breast cancer, breast/chest wall/axillary radiation therapy
Bilateral breast cancer or planned bilateral mastectomy
Participants must be at high risk as defined by a history of breast cancer (invasive or ductal breast carcinoma in situ [DCIS]) and be at least 5 years out from diagnosis, or lobular carcinoma in situ (LCIS), or proliferative benign breast disease such atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH) or genetic test confirmation of BRCA 1/2 mutation carrier or have a breast cancer risk assessment > 1.7% in 5 years or a lifetime risk > 20%
>= 6 months from all previous breast cancer treatment (including endocrine therapy)
Participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of benign core biopsy of this breast will be permitted
Prior bilateral breast surgery (mastectomy, segmental mastectomy, or breast augmentation surgery including breast implants or breast reductions) or combination of breast radiation and surgery involving both breasts
Prior history or evidence of metastatic breast cancer
Prior history of histologically confirmed bilateral invasive breast cancer
COHORT B: No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601
Diagnosis of breast cancer
Pathologically confirmed diagnosis of HER2 positive breast cancer of any stage (previous treatment is allowed without limits on lines of prior therapy)
Previous history or current diagnosis of breast cancer
Patients referred for risk reduction mastectomy (ex. breast cancer (BRCA) or other high-risk gene mutations, strong family history of breast cancer, history of lobular breast carcinoma in situ (LCIS), atypical ductal breast hyperplasia (ADH), atypical lobular breast hyperplasia (ALH) and those with ductal breast carcinoma in situ (DCIS) undergoing bilateral mastectomy or prophylactic contralateral mastectomy)
Patients with a previous diagnosis of invasive breast cancer who are less than 3 years from diagnosis
Patients with an implant in the sampled breast
Moderate risk of developing breast cancer based on either by having at least one of following:\r\n* First or second degree relative with breast cancer age 60 or younger\r\n* Prior breast biopsy\r\n* Prior RPFNA atypia\r\n* Estimated mammographic density of 25% or higher\r\n* Gail 5-year risk of > 1.7% (as calculated by the National Cancer Institute [NCI] Breast Cancer Risk Assessment Tool) or a 5 year Gail Risk of 2X that for age group; and/or\r\n* International Breast Cancer Intervention Study (IBIS) Breast Cancer Risk Evaluation 10-year relative risk of > 2X that for the population for age group
A prior biopsy showing lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer, or individual with breast cancer 1 or 2, early onset gene (BRCA1/2) deleterious mutation
Women at high-risk of breast cancer, as defined by one of the following:\r\n* Cytologically confirmed atypical hyperplasia\r\n* Cytologically confirmed lobular breast carcinoma in situ (LCIS)\r\n* Being a carrier for at least one of the following mutations:\r\n** BRCA1 and/or BRCA2\r\n** TP53\r\n** PTEN\r\n** CDH1\r\n** PALB2\r\n** ATM\r\n** CHEK2\r\n* Predicted lifetime risk of breast cancer > 20% based on family history\r\n* Predicted 10-year risk of breast cancer of >= 2.31%\r\n* Predicted 5-year risk of breast cancer >= 1.67%
Bilateral breast implants
History of any of the following:\r\n* Invasive breast cancer\r\n* Ductal breast carcinoma in situ (DCIS)\r\n* Flat epithelial atypia
Mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the Stefanie Spielman Comprehensive Breast Center or the James Cancer Hospital within the six months prior to study enrollment that are not suspicious for breast cancer (American College of Radiology [ACR] class I-III); subjects with a class IV mammogram may be entered following a negative biopsy
Must be willing to undergo fine needle aspiration of the contralateral breast for breast adipose tissue at 0, 3, 6, 9 and 12 months of the study and breast epithelial tissue samples at 0, 6 and 12 months of study
Subjects with breast implants
Subjects with insufficient breast adipose tissue and/or parenchymal breast tissue/breast density for adequate FNA sampling as determined by clinical examination and/or mammography
Elevated risk of breast cancer as defined by at least one of the following categories and have declined tamoxifen and/or raloxifene therapy:
Must have at least one breast available for imaging and biopsy. A previously irradiated breast (i.e., for resected DCIS) is not evaluable for breast imaging or biopsy. a. Allow for submission of core needle breast material for future use.
Bilateral breast implants. Prior breast reduction surgery is allowed.
Histological confirmation of breast cancer
Breast conserving surgery and indications for whole breast radiotherapy
Recurrent breast cancer
Women scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-II (including ductal carcinoma in situ), or prophylaxis (breast cancer 1, early onset [BRCA1]/2 mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected)
Women with skin diseases (psoriasis, eczema) on the breast
History of prior breast cancer-specific therapy within the previous 2 years; previous unilateral radiation in women scheduled for mastectomy of the contralateral side is allowed
A 1st or 2nd degree relative with breast cancer diagnosed under the age of 60
Multiple prior breast biopsies regardless of histology
If undergoing annual screening mammography, must have been performed within 9 months prior to baseline RPFNA and interpreted either as not suspicious for breast cancer or with any supplementary imaging performed and interpreted as not suspicious for breast cancer
Breast exam interpreted as normal (not suspicious for cancer)
Bilateral breast implants
Invasive cancer diagnosis within five years, excluding squamous or basal cell skin cancer; subjects with DCIS or stage I invasive cancer are eligible if they are at least 2 months from radiation or surgery and at least 1 year (yr) from chemotherapy or hormone therapy; RPFNA will be performed on the contralateral breast only in these instances
Women seeking an RRSO or RRS at MSK, including breast cancer 1 (BRCA 1)/breast cancer 2 (BRCA2) mutation carriers and women with a strong family history of breast and or/ovarian cancer
Breast carcinoma:
Definition of a high risk population: \r\n* The study population will consist of women with a relative risk of developing breast cancer that is at least > 2 x that of the general population for their age group on the basis of any of the following:\r\n** Have a known genetic mutation associated with hereditary breast cancer (including breast cancer [BRCA]1, BRCA2, tumor protein [p]53, etc.)\r\n** One or more first degree relatives with breast cancer, with at least one under the age of 60\r\n** Two or more second degree relatives with breast cancer, with at least one under the age of 50\r\n** Prior biopsy diagnosing atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years\r\n** Have a Gail Risk Assessment (which is based on age, race, age of menarche, age of first live birth, number of first degree relatives with breast cancer, number of breast biopsies, and presence of high risk histology on any biopsies) that is considered high risk compared to the general population: \r\n*** 5 year Gail >= 1.7 or\r\n*** 10 year Gail >= 3.4%\r\n** Prior diagnosis of T1 or T2 breast cancer diagnosed within the last 10 years, without chemotherapy or antiestrogen therapy for > six months and >= 2 months since completion of radiation therapy, when applicable
Barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (FNA) sampling as determined by clinical examination and/or mammogram
Diagnosed with a first primary invasive ER+ breast cancer (stages I-IIIa)
Subjects must have had a normal mammogram or breast MRI within 9 months prior to registration; NOTE: subjects must also have a normal breast exam on the day of the pre-intervention studies
Subjects who have been diagnosed with a prior cancer at any site (other than breast cancer) may participate as long as they have been off medical therapy for at least 12 months prior to registration
Subjects with prior breast cancer must be off all systemic therapy (including endocrine agents) for at least 2 years prior to registration
Carcinoma in situ of the breast
The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III
Prior excisional biopsy of the primary invasive breast cancer
Women (?18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
Subjects with Inflammatory breast cancer.
Breast cancer patients in the expansion cohort must be hormone sensitive or have refractory disease
Patients with inflammatory breast cancer are eligible for the escalation phase of the mastectomy cohort
Inflammatory breast cancer patients are ineligible, except in the escalation phase of the mastectomy cohort
Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
Subject has biopsy-proven multifocal breast cancer
Subject has multi-centric breast cancer
Subject has a history of recurrent breast cancer in the ipsilateral breast
Subject has had previous radiation exposure of the involved breast
Subject has BRCA 1 or 2 mutations. Note: Testing will only be required for Subjects presenting with bilateral breast cancer; testing is not required for unilateral cancers
Life expectancy of at least 5 years, excluding diagnosis of breast cancer (comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)
Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:\r\n* An area of atypia > 2 cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC OR\r\n* Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology
Bilateral mammogram =< 90 days prior to date of surgery; Note: for patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment
Prior history of ipsilateral breast cancer (DCIS, LCIS [lobular cancer in situ] or invasive)
Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed)
Planned partial breast radiation
Carcinoma in situ of the breast
Patients may enroll within 10 years of breast cancer diagnosis, as long as there is a plan for at least 1 more year of adjuvant endocrine therapy
Mammogram negative for breast cancer within the 12 months preceding the time of registration for women >= 50 years of age
Have breast implants
Participants must have a history of histologically-confirmed stage I-III invasive breast cancer or ductal carcinoma in situ (DCIS), Paget’s disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease
>= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy, chemotherapy, trastuzumab and endocrine therapy)
Participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of prior pre-invasive breast cancer or benign biopsy of this breast will be permitted
Mammogram within no more than 6 months prior to the date of informed consent (normal/benign Breast Imaging-Reporting and Data System [BI-RADS] 1 or 2) and no further routine breast imaging planned during the course of the study (12 weeks DHA/placebo)
A history of histologically-confirmed bilateral invasive breast cancer
Prior history or evidence of metastatic breast cancer
Prior history of contralateral (unaffected) breast augmentation with breast implant placement
Patients must be at elevated risk for breast cancer based on strong family history or a history of breast biopsy documenting atypical hyperplasia anytime in the past; for this study strong family history is defined as having:\r\n* 1 first-degree (parent, offspring, sibling) relative =< 50 years old when diagnosed with breast cancer, or\r\n* >= 2 first-degree relatives of any age when diagnosed with breast cancer, or\r\n* >= 2 second-degree (aunts, uncles, grandparents, grandchildren, nieces, nephews, or half-siblings) maternal or paternal relatives diagnosed with breast cancer and at least 1 diagnosed at =< 50 years of age
Diagnosis of stage I-IIIA breast cancer within past 5 years (confirmed by medical record review)
Treatment with total mastectomy and axillary dissection; or breast-sparing surgical removal of cancer with clear macroscopic margins and axillary dissection; followed by adjuvant breast radiation
Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies
Clinical and/or radiographic evidence of residual or persistent breast cancer
Post-menopausal woman with a diagnosis of invasive breast cancer (T1-3,pN0-2,M0) for which definitive surgery was performed during the previous 36 months.
Known recurrence of breast cancer (local, regional or distant) at any time prior to study entry.
Patients must have breast or ovarian cancer
Pathological diagnosis of invasive adenocarcinoma of the breast
Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery
Bilateral breast malignancy or suspicious mass in opposite breast
History of prior breast cancer, ductal carcinoma in situ
Patients must be undergoing breast conserving therapy
Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible
T4 tumors including inflammatory breast cancer
Patients with synchronous ipsilateral invasive breast cancer or any prior history of ipsilateral invasive breast cancer; (patients with previous ipsilateral/contralateral DCIS or previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible)
No patients with previous ipsilateral or contralateral invasive breast cancer or ductal carcinoma in situ (DCIS)
No patients with bilateral breast cancer
No patients with known deleterious mutations in breast cancer (BRCA) genes
No patients scheduled to receive partial breast irradiation following breast conserving surgery
Personal history and/or concomitant diagnosis of invasive breast cancer or DCIS
Patients with biopsy-proven breast cancer
Patients with a prior history of ipsilateral breast cancer
Operable breast cancer treated with NAC undergoing either breast conservation or total mastectomy who have had a post-NAC clinical bilateral breast MRI demonstrating a complete imaging response, which is defined as no residual tumor enhancement
Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram
Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for breast cancer therapy [BCT], and the ability to undergo standard radiation therapy post-operatively)
Participants with inflammatory breast cancer or multi-centric disease
Diagnosed with a Breast Imaging Reporting and Data System (BI-RADS) score of 4 or higher breast abnormality greater than 1cm in size
Diagnosed with histologically-proven invasive breast cancer
Prescribed neoadjuvant chemotherapy for breast cancer
Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for breast-conserving surgery [BCS], and the ability to undergo standard radiation therapy post-operatively)
Participants with a known breast cancer (BRCA) 1 or 2 mutation
Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin
Participants with prior history of ipsilateral breast carcinoma
Patients undergoing a partial mastectomy OR mastectomy for the treatment of an invasive or non-invasive breast malignancy
Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.5 cm in diameter by any imaging modality
Biopsy-proven PR-positive (sample size [N]=23) or PR-negative (N=5) invasive breast cancer, as defined by University of Wisconsin (UW) Health Pathology
Patients with breast implants or expanders
New diagnosis of breast cancer
New diagnosis if a previous breast cancer patient with negative surgical margins
Women with history of surgical, medical, or radiation therapy for breast cancer
Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas
Breast cancer (any stage)
Known or suspected (Breast Imaging Reporting and Data System [BIRADS] 5 on imaging) primary breast cancer
At least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast magnetic resonance imaging [MRI]); only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study; patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included
Inflammatory breast cancer
Prior history of breast cancer in the ipsilateral breast
Previous radiation to the breast or axilla
Patient of Dr. Ranjna Sharma’s scheduled to undergo lumpectomy for breast cancer at Beth Israel Deaconess Medical (BIDMC)
Core needle biopsy positive for invasive breast cancer or ductal breast carcinoma in situ (DCIS)
Involvement in another therapeutic trial for breast cancer at Dana Farber or elsewhere
No prior history of breast cancer
Known or suspected breast cancer with at least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast magnetic resonance imaging [MRI]); only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study; patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included
Have biopsy-proven breast cancer and decided to receive neoadjuvant chemotherapy
PATIENT: Be diagnosed with breast cancer
PATIENT: Patients who have had prior breast reduction
Patients who will receive radiotherapy as treatment for left-sided breast cancer
Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:\r\n* New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment \r\n* Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with aromatase inhibitors [AIs] or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET
Has biopsy-proven invasive breast cancer (Breast Imaging Reporting and Data System [BI-RADS] 6) and scheduled for neoadjuvant chemotherapy (NAC)
Patients with stage T1 or greater (T1-T4), nodal involvement (N0-N3), without metastasis (M0) invasive breast cancer, including patients with inflammatory breast cancer
The patient must have a histologically proven diagnosis of stage I through IIIC breast cancer
Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease
High risk: this includes patients with any of the following:\r\n* >= 20% lifetime risk of breast cancer\r\n* Breast cancer, early onset (BRCA) mutation or other hereditary germ line mutation\r\n* History of chest wall radiation\r\n* Lobular carcinoma in situ (LCIS)\r\n* History of breast cancer diagnosed at age 40 or earlier\r\n* History of breast cancer with 1st or 2nd degree relative with breast cancer and either patient or relative diagnosed at 50 years or younger\r\n* History of breast cancer with mammographically occult lesions\r\n* History of breast cancer for whom a medical oncologist feels breast MRI screening is important
Scheduled for breast core needle or surgical biopsy of at least one breast lesion based on suspicious breast lesion (Breast Imaging Reporting and Data System [BIRADS] score of 4 or 5) from pre-study standard of care (SOC) imaging studies
Pathologic diagnosis of invasive breast cancer or high suspicion of breast cancer based on imaging
Participants who are breast cancer free (mammogram “negative” within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with stage II or stage III breast cancer will be invited to participate in the study
Females s/p treatment for breast cancer within last 5 years
Scheduled for mammogram, breast ultrasound and/or breast MRI
No open breast or chest wounds
Patients scheduled to have a partial mastectomy or mastectomy for the treatment of breast cancer
No known or suspected breast disease
Symptomatic of any breast abnormality
Recent breast biopsy
Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
Biopsy confirmed malignancy associated calcifications in at least one breast
Biopsy confirmed benign calcifications in at least one breast (same or contralateral breast)
Patients who have received prior treatment for the current breast cancer
with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;
and in good health (other than having breast lesions);
Patients with a confirmed diagnosis of clinical stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or mastectomy and planned axillary sentinel node biopsy procedure will be eligible for the study
Patients with cancer > 3 cm, clinically positive nodes, prior surgery for breast cancer in the index breast, thyroid dysfunction, hypersensitivity to iodine, and hepatic or renal insufficiency will be excluded from the study
Subjects with known or suspected breast disease
Have been diagnosed with a HER2+ invasive cancer of the breast
Group I: Diagnosis of histologically confirmed invasive breast cancer
Group II: Diagnosis of histologically confirmed invasive breast cancer
Women undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer (ductal carcinoma in situ [DCIS] or any invasive breast cancer)
Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy
Patients with breast implants
Serious systemic illness other than breast cancer
Unresected, untreated breast cancer that meets one of the following clinical stages:\r\n* T2, T3, or T4a-c lesion, any N, M0\r\n* Note: Patients with inflammatory breast cancer (T4d) are not eligible; bilateral cancers are permitted with approval of the Protocol Chair; participants with clinically evaluable disease will be followed for response by clinical examination; measurable disease is not required for participation
Received prior or ongoing local (e.g radiation) or systemic treatment (chemotherapy or endocrine therapy) for the current breast cancer; patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least one month prior to baseline study biopsy
BREAST CANCER PARTICIPANTS: Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s)
BREAST CANCER PARTICIPANTS: Patient is able to remain still for duration of each imaging procedure
BREAST CANCER PARTICIPANTS: Patients participating in other research imaging protocols will be excluded from this study
Women with stage I-III breast cancer who began their cancer treatment 1-2 years prior to this study and have received anthracycline based chemotherapy
Women with histologically confirmed breast cancer (by core needle biopsy)
Women with >= 2 cm clinically or radiologically measureable breast cancer
Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
Women who have had a prior history of breast cancer in the same breast
Patient must have a tissue diagnosis of invasive breast carcinoma
Patient has concurrent invasive bilateral breast malignancies or multicentric disease
Multicentric breast cancer
Required studies include diagnostic mammogram of the affected breast within 3 months prior to registration, and a two-view (full view craniocaudal [CC] and a full view mediolateral oblique [MLO]) mammogram of both breasts within 6 months of registration (if the patient has only one breast, a unilateral exam of the intact breast is required)
Patients must not have previous ipsilateral invasive breast cancer or DCIS
Patients must not have known deleterious mutations in breast cancer (BRCA) genes
No prior history of breast radiotherapy that will prevent the use of radiotherapy for the present DCIS
Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
The cancer enhances on breast MRI imaging
Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
Multicentric breast cancer, defined as two or more tumors in different quadrants of the breast
Any history of prior radiation or chemotherapy for breast cancer
Have bilateral breast cancer
Will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist
Have a recurrence of ipsilateral breast cancer
Patients with DCIS or invasive breast cancer who are scheduled for a lumpectomy or mastectomy and are receiving surgical care from the Breast Surgery Department at Columbia Medical Center
Patients diagnosed with unilateral DCIS or invasive breast cancer
Patients with a prior breast cancer diagnosis
Patients with invasive, inflammatory breast cancer or distant metastases will be excluded from participating in this study
Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).
Ipsilateral biopsy-proven invasive breast cancer < 5 cm in maximal dimension by ultrasound or mammography
Prior history of ipsilateral breast cancer
Women at high-risk of breast cancer with an order for a clinical screening breast MRI
Women diagnosed with breast cancer within the last 6 months
A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III
Women with histologically proven invasive breast cancer and no distant metastases and;
Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer.
Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer.
Patient must have a histologic diagnosis of invasive breast cancer
The primary breast tumor must be detectable by mammogram or breast ultrasound at the time of diagnosis
The patient is diagnosed with non-invasive breast cancer, benign breast disease, or other than stage II or stage III invasive breast cancer
Have a prosthesis/implant in the operative breast
Participants must have been clinically diagnosed with breast cancer and scheduled for axillary lymph node dissection (ALND) and radiation treatment at MD Anderson (receiving chemotherapy, mastectomy or breast-conserving surgery, ALND (>10 nodes) and radiation treatment for breast cancer, identified by Drs. Mittendorf and Shaitelman of the Nellie B. Connally Breast Cancer Center at MD Anderson)
Severe underlying chronic illness or disease (other than breast cancer)
Diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage I or II, ER positive or negative breast cancer, or ductal carcinoma in situ (DCIS)
Prior invasive breast cancer, prior mastectomy or breast radiation within 12 months
For participants with breast cancer only:
Stage I-IIIc disease:\r\n* Scheduled for lumpectomy or mastectomy\r\n* No prior or current therapy for breast cancer\r\n* Not considered candidate for therapeutic neoadjuvant treatment
Patients must have histologically confirmed invasive breast cancer
Newly diagnosed primary breast cancer prior to initial definitive surgical treatment, including in situ and invasive cancer, stages 0 – III; pathologic confirmation of diagnosis is required
PHASE I: Women with estrogen receptor (ER)+, HER2-, lymph node (LN)-, breast cancers < 3 cm who were diagnosed with a first primary breast cancer > 6 months ago and < 2 years ago
PHASE I: Women diagnosed with Paget’s disease, inflammatory breast cancer or a phyllodes tumor
PHASE I: Women who state that there are still deciding on breast cancer treatment (e.g., whether or not to take hormone therapy or to receive radiation treatment)
PHASE II: Women with a history of breast cancer (invasive and non-invasive) and those diagnosed with Paget’s disease, inflammatory breast cancer or a phyllodes tumor
Within 6 weeks of a new line of breast cancer therapy and/or progression on scans and/or a change in current breast cancer therapy regimen
Patient: Had a mastectomy for breast cancer no more than 5 years prior to enrollment
Surgeon: Performs breast reconstruction procedures after mastectomy
Nurse: Involved in the perioperative care of patients with breast cancer
Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic.
Diagnosis of invasive breast cancer
Breast implants allowed
Stage 4 breast cancer
Prior treatment with radiation therapy to the ipsilateral breast or chest wall\r\n* Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry\r\n* Prior invasive or in-situ carcinoma of the breast (-prior lobular breast carcinoma in situ [LCIS] is eligible)\r\n* Diagnosis of ductal breast carcinoma in situ (DCIS)
Diagnosed with hormone receptor-positive breast cancer and prescribed endocrine hormonal treatment (EHT)
Newly diagnosed female breast cancer patients scheduled to see one of four breast surgeons at the Huntsman Cancer Hospital Breast Surgery Clinic at the University of Utah
Patients who have had breast cancer previously
Latinas diagnosed with breast cancer
Attend the Cancer Therapy and Research Center (CTRC) breast clinic
A primary diagnosis of stage 0 (ductal carcinoma in situ), 1, 2, or 3a breast cancer
Patient’s breast cancer has not recurred during the time period
No prior treatment with chemotherapy for a diagnosis of locoregionally recurrent or metastatic breast cancer is allowed.
Histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or a combination of invasive breast cancer and DCIS. Subjects who had diagnostic surgical biopsies are excluded from participation.
Pregnant at the time of diagnosis of their breast cancer.
Prior ipsilateral breast cancer surgeries, mastectomies, breast reconstructions or implants.
Prior ipsilateral reduction mammoplasties (breast reductions) performed less than 2 years prior to enrollment to this study.
Breast cancer non-candidate for hormone therapy alone.
Diagnosis of primary breast cancer.
Diagnosed with invasive adenocarcinoma, or DCIS for which a SLNB is the recommended standard of care, or breast cancer with all of the following conditions met:
positive clinical breast examination
Prior breast malignancy of the ipsilateral breast.
Patient currently receiving or had prior treatment for the currently diagnosed breast cancer.
Subjects with prior breast surgeries, mastectomies, breast reconstructions or implants. (Note: subjects who have had prior breast biopsies are not excluded)
Has locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.
Has completed treatment for Stage I-III breast cancer, if indicated, and ?6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
Adult women with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology
Women with T4 disease, including inflammatory breast cancer
Patients with synchronous bilateral breast cancers
Confirmed current or past diagnosis of invasive breast cancer
Histopathologically confirmed metastatic breast cancer
At least 2 prior HER2-directed therapy regimens for metastatic breast cancer, including trastuzumab and TDM-1.