The patient has metastatic disease or locally recurrent, unresectable disease
Patients must not have metastatic disease (i.e., must be M0); patients must not have locally recurrent disease
Subjects must have histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease; locally recurrent disease must not be amenable to any local treatment with curative intent; metastatic disease must be demonstrated either radiographically or histologically
Locally recurrent breast cancer
PROCUREMENT INCLUSION CRITERIA: Any breast cancer patient with metastatic or locally recurrent unresectable disease
Evidence of measurable, locally recurrent or metastatic disease based on imaging studies within 28 days before the first dose of study drug.
Has received at least 1, but no more than 2, prior lines of systemic therapy for locally recurrent and/or metastatic disease.
For Cohort B: No prior chemotherapy for inoperable locally advanced or metastatic or recurrent UCa and ineligible (\unfit\) for cisplatin-based chemotherapy;
More than 1 line of prior chemotherapy in the treatment of metastatic or locally advanced/recurrent disease.
Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted
Histologically and/or cytologically documented and radiographically measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) adenocarcinoma of the esophagus or stomach (HER2-positive or negative) that is metastatic/recurrent and not amenable to potentially curative treatment (e.g., inoperable metastatic or locally recurrent disease)
Has been a participant in Study WRI-GEV-007, \A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients\
Prior radiation or surgery to the esophagus is permitted for patients with locally recurrent/persistent disease
Metastatic and/or locally advanced or locally recurrent disease that is not surgically resectable
Locally recurrent resectable breast cancer
Histologic or cytological diagnosis of SQCLC with advanced/metastatic stage, with no known curative treatment options; prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation therapy given for locally advanced disease is considered first line therapy only if recurrent (local or metastatic) disease developed within 6 months of completing therapy; subjects with recurrent disease > 6 months will be eligible
Patients must have histologically-proven locally-recurrent or metastatic solid tumor; the first 10 patients may have cancer of any histology; preference will be given to patients with metastatic ovarian cancer, breast cancer, and malignant melanoma, as these malignancies have been shown to be sensitive to manipulation of the beta-adrenergic receptor; the final twenty-five patients to be accrued must have locally-recurrent or metastatic malignant melanoma that is not surgically resectable
Locally recurrent/metastatic.
Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease confirmed as described below; eligible patients include those with either:\r\n* De novo metastatic disease presenting without prior history of HER2-positive breast cancer:\r\n** Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient\r\n* Locally recurrent or metastatic disease following prior therapy for early breast cancer:\r\n** Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease\r\n** There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy
Locally recurrent breast cancer
TNBC must be either locally recurrent or metastatic; locally recurrent disease must not be amenable to surgical resection or radiation with curative intent
Patients have locally recurrent or distant relapsed metastatic disease
Metastatic disease or incurable locally recurrent disease
Confirmed diagnosis of HR-negative, HER2-negative (locally recurrent or metastatic TNBC) breast cancer
More than 2 prior chemotherapy regimens for locally recurrent or metastatic TNBC. If ? 12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy administration and first documented local or distant disease recurrence the therapy will not be considered a line of therapy in the locally recurrent or metastatic TNBC setting.
Locally recurrent/metastatic
Inoperable, locally recurrent or metastatic disease (tumor resectability should be assessed by a local surgeon or multidisciplinary team)
Locally advanced, recurrent, or metastatic incurable solid malignancy with measurable disease per RECIST v1.1
Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer
Participant has not received prior biologic therapy for metastatic or locally recurrent and inoperable breast cancer
Metastatic or locally recurrent TNBC
Solid tumor that is metastatic, locally advanced or recurrent
Locally recurrent resectable breast cancer
Patients must be untreated with chemotherapy for metastatic or locally recurrent disease; prior radiation therapy is permitted
Surgically unresectable locally recurrent disease and/or metastatic disease following RAI ablation (if locally recurrent and ultrasound (US) positive, baseline FDG-PET or MRI will be obtained).
ErbB-2 positive locally recurrent or metastatic breast cancer
Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease.
Prior chemotherapy for metastatic or locally recurrent disease Exceptions:
Prior immunotherapy for metastatic or locally recurrent disease
Patient has locally recurrent or metastatic disease
Subjects who have locally recurrent or metastatic disease with at least one measurable lesion
Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2 breast cancer.
Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
Patient must have received at least one prior treatment for recurrent, metastatic and/or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease o Patients with breast cancer overexpressing HER2 are not eligible.
Patients must have evidence of recurrent, locally advanced, or metastatic disease.
Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
Locally recurrent or metastatic breast cancer
Presence of residual or recurrent cancer (locally or metastatic)
Diagnosis of locally advanced, recurrent, or metastatic disease.
Metastatic or locally recurrent unresectable breast cancer
Locally recurrent or metastatic disease
Ovarian cancer
Patients may not have had any prior systemic therapy =< 21 days prior to registration for treatment of ovarian cancer
Histologically or cytologically confirmed advanced ovarian cancer: epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (excluding borderline ovarian cancer) that is resistant or refractory to platinum therapy and no other standard therapy with proven clinical benefit is available.
Part 2: Ovarian or HNSCC, with confirmed p53 mutations
For the dose expansion cohort, patients with recurrent endometrial cancer, recurrent BRCA mutated ovarian cancer (except first-recurrence platinum sensitive ovarian cancer), and platinum resistant ovarian cancer are eligible
For the dose expansion cohort patients with first-recurrence platinum-sensitive ovarian cancer must be excluded
Ovarian cancer of serous histology
Patients with platinum resistant ovarian cancer must have progressed through at least one prior chemotherapy regimen for recurrent ovarian cancer
History of blocked intestines because of ovarian cancer, unless fully resolved.
Treatment with cytotoxic chemotherapy for malignancies other than ovarian cancer within the past 5 years
gBRCAm ovarian cancer (modules 3 and 5)
gBRCAm negative ovarian cancer (modules 6 and 7)
Subjects with ovarian and endometrial cancer (endometrial cancer only in the expansion cohort) with:
Subjects with comorbidities that would limit their two year survival for reasons other than ovarian cancer
EXCLUSION CRITERIA FOR REGISTRATION: subjects with comorbidities which would lead to a clinical expectation that they will not survive two years for reasons other than ovarian cancer
Any prior treatment for ovarian cancer, other than the first-line platinum regimen
Previous chemotherapy or hormonal therapy for treatment of ovarian cancer.
Participants must have primary or secondary platinum-resistant ovarian cancer.
Diagnosis of clear cell or low grade ovarian cancer
Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
Phase 2 expansion: Ovarian cancer
Phase 1 patients (breast or ovarian cancer)
Phase 2 patients (breast or ovarian cancer)
Ovarian Cancer
Patients must have received at least one prior salvage regimen for recurrent ovarian cancer
Prior therapy for ovarian or uterine cancer with ribociclib or an aromatase inhibitor (letrozole, anastrozole or exemestane)
Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
Previous treatment with > 2 anticancer regimens for ovarian cancer
Has epithelial ovarian cancer (EOC) with mucinous histology subtype
Ovarian cancer confirmed BRCA wild-type from a prior test.
Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free interval
Ovarian Carcinoma
Patients may have synchronous endometrial and ovarian cancer primaries
More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.
Have been diagnosed with noninvasive or invasive (stage 1, 2, or 3A) breast cancer, colon cancer, lymphoma, or ovarian cancer
History of breast cancer, endometrial cancer or ovarian cancer or taking aromatase inhibitors or selective estrogen receptor modulators
Metastatic ovarian epithelial cancer that are platinum-resistant, and has no better option available in the investigator's opinion
Part 2 includes target expressing NSCLC, ovarian or breast cancer patients
Systemic drug treatment to induce ovarian suppression if woman is premenopausal
Prior treatment with paclitaxel and carboplatin for recurrent platinum-sensitive ovarian cancer
Not more than two prior chemotherapy regimens for the treatment of platinum-resistant ovarian cancer Participants with Pancreatic Cancer:
Epithelial ovarian cancer or gynecological cancer
Less than 4 weeks since last treatment for ovarian cancer
Breast cancer in BRCA1 or BRACA2 positive ovarian cancer patients
For ovarian cancer participants only, platinum treatment with more than two platinum-based chemotherapy regiments or more than four anti-cancer regimens, overall, for the treatment of ovarian cancer.
Borderline ovarian cancer with ascites
Non-epithelial ovarian cancer or metastatic cancer to the ovaries
Borderline ovarian cancer without ascites
Presumed early stage ovarian cancer
Patients with borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian cancer are not eligible
PATIENTS: Platinum-sensitive recurrent ovarian cancer without a significant clinical event
Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
Does not plan to undergo ovarian stimulation and oocyte retrieval prior to diagnosis
Prior genetic counseling or testing for hereditary breast/ovarian cancer
Any condition which might be worsened by estrogen, such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids
Women with a history of leukemia, ovarian cancer or a cancer that likely involve the ovaries at the time of ovarian tissue collection
Have blood relatives diagnosed with ovarian cancer
Have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer
Ongoing treatment for ovarian or other cancer (e.g., chemotherapy, radiation, surgery, etc.)
Confirmed diagnosis of primary breast, cervical, endometrial, or ovarian cancer
Pilot: Ovarian cancer patients who have completed cancer treatment
ovarian cancer: 2-4 prior treatments
Diagnosis of clear cell or low grade ovarian cancer
Patients with recurrent ovarian cancer receiving chemotherapy
Diagnosis of stage III-IV epithelial ovarian cancer (EOC)
Stage I-IV gynecologic cancer (including ovarian, uterine, cervical, vulvar, or vaginal cancer)
Have one relative with ovarian cancer
Scheduled for surgery at Brigham and Women’s Hospital for known or highly suspected stage III or IV ovarian cancer (i.e. elevated cancer antigen [CA]-125 with a pelvic mass, ascites, and carcinomatosis)
Active malignancy other than ovarian cancer
No measurable disease or suspected stage I or II ovarian cancer on preoperative imaging
Patients with prior ovarian cancer or surgery involving removal of one or both ovaries
History of ovarian cancer
Ovarian cancer:
Patients must have breast or ovarian cancer
Patients must have completed primary breast or ovarian cancer therapy (i.e., surgery, chemotherapy, immunotherapy and/or radiation therapy as appropriate per standard of care for patient's specific cancer)
Women must be enrolled in the Ovarian Cancer Screening Program (OCSP); eligibility criteria for the OCSP are: 50 years of age or older, or be postmenopausal and have not had a prior salpingo-oophorectomy or have a family history of ovarian cancer in a primary relative or have a self-history of breast cancer
Patients have a documented ovarian abnormality on ultrasound
History of ovarian cancer
No prior treatment for ovarian cancer
Patients who have non-invasive or non-epithelial ovarian cancer on pathological confirmation; patients with synchronous stage I endometrial cancer will not be excluded
OVARIAN CANCER PARTICIPANTS: Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo surgical excision of the cancerous lesion(s) OR\r\n* Participant has biopsy proven ovarian cancer but is not a surgical candidate
OVARIAN CANCER PARTICIPANTS: Patients participating in other research imaging protocols will be excluded from this study
Epithelial ovarian cancer which is contained within the abdomen, but may include pleural effusion if that is the limit of non-peritoneal cavity disease. If subject has recurrent epithelial ovarian cancer, the disease must be platinum sensitive (recurrence >6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery)
Borderline ovarian cancer with ascites is allowable
Non-epithelial ovarian cancer or metastatic cancer from another site to the ovaries
Borderline ovarian cancer without ascites
Female patients 18 years of age and older 2. Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and:
Evaluable disease by serum markers in the case of ovarian cancer [Gynecologic Cancer Intergroup (GCIG) specific criteria]; and
Known FR alpha-negative ovarian cancer
Chemotherapy administered for the currently diagnosed breast cancer prior to randomization
An excisional biopsy of this breast cancer
Any radiation therapy for the currently diagnosed breast cancer prior to randomization
Any radiation therapy (RT) for the currently diagnosed breast cancer prior to study enrollment
Expanded Cohort: must have breast cancer.
Prior malignancy, other than breast cancer, active within the last 6 months
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
Any prior systemic therapy for breast cancer within 5 years
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
Breast cancer patients
Prior systemic therapy for treatment and prevention of breast cancer
Any radiation therapy for the currently diagnosed breast cancer prior to randomization
Recurrent breast cancer
Prior history of breast cancer.
Planning to remain on current breast cancer therapy for at least 12 weeks
HER2 positive breast cancer
Women with pathologically demonstrated breast cancer
Male breast cancer patients.
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
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
Prior systemic therapy for indexed breast cancer
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
Patients must not have received prior treatment for the current breast cancer
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
Any other presurgical therapy for breast cancer
No prior treatment with therapeutic intent for breast cancer
Previous history of breast cancer (even in the other breast)
Evidence of progressive breast cancer within the last 30 days
A prior, unrelated, breast cancer is allowed
All stages of breast cancer are eligible
Evidence of progressive breast cancer within the last 30 days
Hormone unresponsive breast cancer
Prior systemic therapy for the indexed breast cancer
Male breast cancer
Prior therapy for breast cancer
Subjects must not have received any other breast cancer-specific therapy for the current breast cancer diagnosis prior to registration
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
Prior radiation therapy for the current breast cancer
Previous breast cancer and /or radiation in the operated breast.
Breast cancer
A prior, unrelated, breast cancer is allowed
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
No prior chemotherapy for this primary breast cancer
Prior radiation therapy for breast cancer
Candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon
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
Breast cancer must be HER2-negative.
HER2 positive breast cancer
Has pathologically documented breast cancer that:
Exceptions are breast cancer in the other breast.
Part B: Breast Cancer
The subject has AR+ breast cancer
The subject has a history of a non-breast cancer malignancy with the following exceptions:
Patient has HER2-negative breast cancer
HER2-positive breast cancer
12 patients with breast cancer for whom 5 FU chemotherapy is the standard treatment
Patients with biopsy-confirmed breast cancer
An excisional biopsy of this breast cancer
The cancer enhances on breast MRI imaging
=< 90 days from the patient’s most recent breast surgery for this breast cancer
HER2-positive breast cancer confirmed by a central laboratory
HER2-positive breast cancer
Patients who have received a previous HER2 breast cancer vaccine
=< 90 days between the planned treatment start date and the patient’s most recent breast surgery for this breast cancer
Prior treatment for the currently diagnosed breast cancer
Prior therapy for the treatment of breast cancer is not allowed
HER2-positive breast cancer
Subjects with prior history of cancer in the ILT treated breast
Subjects with recurrent breast cancer
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
Recurrent breast cancer
Breast cancer: Patients with Her-2 negative breast cancer after anthracycline and taxane based chemotherapy.
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)
Previous excisional biopsy of the breast cancer
Any prior breast cancer
Multicentric breast cancer
Breast cancer eligible for primary surgery
Breast cancer
Breast cancer
For subjects with breast cancer:
No current evidence of breast cancer
Recurrent breast cancer or other malignancy
Has received more than 1 prior antiangiogenic agent for breast cancer
Recurrent breast cancer or history of prior breast radiation therapy
Breast cancer requiring bilateral breast/chest wall radiation therapy
Male breast cancer patients
Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis following the breast cancer (excluding non-melanoma skin cancer)
Pathologically confirmed breast cancer
BREAST CANCER COHORT:
No prior therapy for current breast cancer
Evidence of recurrent breast cancer at the time of enrollment
History of recurrent breast cancer (with a prior history of chemotherapy)
Must not have had history of breast cancer, breast surgery, radiation to the chest wall
Having received chemotherapy as part of their primary therapy for breast cancer.
Any medical treatment for breast cancer will be allowed
Subjects will not have breast surgery as a portion of their breast cancer care
Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past 5 years will be included
Recurrence of breast cancer
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
History of prior breast cancer surgery
Breast cancer survivors
Breast cancer at age 50 or below
Have 2 or more blood relatives diagnosed with breast cancer
A first degree relative diagnosed with breast cancer below age 50
Have any male relatives diagnosed with breast cancer
Belongs to a breast cancer support group
Must have completed local therapy for 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
Prior treatment of gynecologic or breast cancer with chemotherapy
Have completed curative treatment for breast cancer
Pathologically confirmed breast cancer
Diagnosed with breast cancer
Node-negative left breast cancer
Male breast cancer survivors
Pathologically confirmed HER2-positive breast cancer
Have a history of breast cancer
No prior chemotherapeutic treatment for any malignancy other than breast cancer
Pathologic documentation of breast cancer
Have been diagnosed with breast cancer
Women with breast cancer who plan to undergo radiation therapy to the breast or chest wall
Women with breast cancer involving the skin
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
Do not have a history of breast cancer
Diagnosed with breast cancer at age 45 or younger
Have one male relative with breast cancer
Patients with known 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
BREAST CANCER SURVIVORS: Has histologically-confirmed, first-time breast cancer (stage I-IIIB);
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
Prior history of breast cancer, breast/chest wall/axillary radiation therapy
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
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%
Recurrent breast cancer
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
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
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
Women with history of surgical, medical, or radiation therapy for breast cancer
No prior history of breast cancer
PATIENT: Be diagnosed with breast cancer
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
Patients who have received prior treatment for the current breast cancer
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
Serious systemic illness other than breast cancer
BREAST CANCER PARTICIPANTS: Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s)
Women who have had a prior history of breast cancer in the same breast
Multicentric breast cancer
The cancer enhances on breast MRI imaging
Any history of prior radiation or chemotherapy for 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
For participants with breast cancer only:
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
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
Patient’s breast cancer has not recurred during the time period
Patients with a history of a different malignancy are excluded, unless the disease has not progressed for >= 2 years
History of other malignancy within 2 years prior to screening
Participants with other active malignancy in the past 3 years excluding in situ tumors
Any other current or previous malignancy within 3 years except protocol allowed malignancies
Past or present malignancy within the last 5 years.
History of another malignancy within 3 years of the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
History of malignancy other than MM within the past 3 years
Has a history of a second malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 2 years.
History of malignancy other than B-NHL within the past 3 years with the exception of:
History of other active malignancy within past 2 years.
Prior other malignancy within 2 years (except for in situ disease, which is permissible).
Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 3 years before randomization.
Active second malignancy, i.e. patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment; patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy for prior malignancy was completed > 12 months prior and/or bone marrow transplant > 2 years prior
Active malignancy (other than melanoma) or a prior malignancy within the past 3 years
Prior malignancy (other than breast cancer) unless diagnosed and definitively treated more than 5 years prior to randomization.
Other malignancy requiring treatment in the prior 2 years
History of malignancy other than NSCLC within 2 years prior to screening
Has history of other active malignancy within 3 years prior to enrollment, except:
Patients must not have received treatment for another malignancy within 3 years of enrollment
Prior malignancy or therapy for a malignancy within 3 years
Participants with presence of other active malignancy within 2 years of study entry; participants with history of prior malignancy treated with curative intent and achieved CR within 2 years are eligible.
Other malignancy within 2 years prior to screening, with some exceptions
Active malignancy besides NSCLC within 3 years prior to screening.
No prior history of malignancy within 2 years, unless cured of a skin cancer or a stage I-III solid tumor; no prior hematologic malignancy within 3 years
Subjects with a history of prior malignancy with the exception of carcinoma in situ of the cervix or other malignancy diagnosed > 2 years ago that has undergone potentially curative therapy with no evidence of disease for the last >= 2 years and that is deemed by the investigator to be at a low risk of recurrence
Patients with prior malignancy and treated with no evidence of active disease, and more than 2 years from initial diagnosis are eligible
History of other malignancy within the last 3 years (with exceptions).
Participants with a history of other malignancy within 5 years prior to screening
Previous malignancy within 2 years of the first dose of study drugs, except tumors totally resected and/or not requiring therapy
A history of other malignancy =< 5 years previous which would preclude endocrine treatment of their cancer
No active prior malignancy within 3 years of registration (with the exception of non-melanoma skin cancer, in-situ cancers, or Rai stage 0 chronic lymphocytic leukemia [CLL]); if patient is disease free from a prior malignancy between 3-5 years, special consideration can be requested; in these cases, if the risk of recurrence at 5 years is less than 20%, and in the opinion of the investigator the prior malignancy will not affect the patient's outcome in light of newly diagnosed pancreatic cancer, the patient may be eligible; this will require principal investigator (PI) review and approval on a case by case basis, and approval will be documented in the medical record; all patients who have been disease free from a prior malignancy for at least 5 years will be eligible
Prior malignancy (EXCEPTION: diagnosed > 5 years ago without evidence of disease, OR treated =< 5 years ago but have a greater than 50% chance of life expectancy of >= 5 years for that malignancy)
Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol
Previous other malignancies unless they have undergone curative intent therapy for that malignancy and (1) have had no evidence of that disease for 5 years, and/or (2) be deemed at low risk for recurrence (less than or equal to 20% at 5 years)
Previous chemotherapy for any malignancy, if given within three years of registration
Other malignancy within five years, except the following may be eligible:
No chemotherapy for a malignancy in the last 5 years
Patients with a prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible
Malignancy within the last 3 years
Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol
Patients with a history of another malignancy within 5 years of study enrollment
Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)
Individuals with a history of a previous malignancy are ineligible; exception: individuals with a previous malignancy treated with surgery only (no chemotherapy or radiotherapy) more than 5 years prior to registration may be enrolled
History of other malignancy within 2 years prior to screening
Presence of malignancy other than the study indication under this trial within 3 years of study enrollment
History of other malignancy within the last 5 years
Have a concurrent malignancy or had another malignancy within 5 years (?5 years) of study enrollment.
History of any other malignancy other than skin cancer, or low grade bladder cancer which has been completely resected, within the previous 2 years. Patients that have had curative treatment of a previous malignancy and no recurrence of that malignancy within the past 2 years will be allowed.
Diagnosed with another malignancy within the past 3 years
Have prior malignancy active within the previous 2 years;
Dose Expansion Phase only: diagnosis of any other malignancy within 2 years prior to registration.
History of other malignancy with the past 2 years with some exceptions
Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).
Any active malignancy (other than BRAF-mutated melanoma) or a previous malignancy within the past 3 years
History of other malignancy within the past 3 years with the following exceptions:
There is any evidence of other malignancy being present within the last three years;
Patient has a history of hematological malignancy within the last 5 years prior to study entry
History of another malignancy within 3 years
Participants with a previous malignancy within the past 3 years
Subjects with history of other malignancy within past 5 years (with exceptions)
Other malignancy within the last 5 years
Any other current or previous malignancy within 3 years except protocol allowed malignancies
Active malignancy of metastatic potential other than the known carcinoid or pancreatic NET within the past three years
Other malignancy within 2 years prior to Day 1 of the study, except for those treated with surgical intervention only.
Any prior history of hematologic malignancy (other than CTCL) within past 5 years
Other malignancy within five years, except that the following may be eligible:
Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
Presence of malignancy other than the study indication under this trial within 5 years of study enrollment
History of metastatic malignancy in the preceding 2 years
Active treatment/chemotherapy for another primary malignancy within the past 5 years
Subjects with no additional active malignancy within the last 3 years
Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible; patients with a prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible
History of metastatic malignancy in the preceding 2 years
Diagnosed with another primary malignancy in the past 3 years
Diagnosis of another malignancy within 2 years before first dose of study treatment.
History of prior malignancy within 3 years; patients who are considered no evidence of disease (NED) from a malignancy may be considered on a case by case basis
Other malignancy within the last 5 years (few exceptions apply);
Patients with a prior malignancy allowed if > 5 years ago with no current evidence of disease
Active or recent second malignancies unless they have undergone potentially curative therapy for that malignancy and (1) have had no evidence of that disease for 5 years, and/or (2) be deemed at low risk for recurrence (less than or equal to 20% at 5 years)
Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible; patients with a prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible
History of other active malignancy within the prior 2 years
Has a history of a malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years
Patients with evidence of another malignancy (exclusive of a skin cancer that requires only local treatment);\r\n* Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible\r\n* Patients with prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible
Patients with another malignancy within the past 5 years
Presence of any other malignancy or history of prior malignancy within 5 years of study entry; within 5 years, patients treated for stage I or II cancers are eligible provided they have a life expectancy > 5 years in relation to this prior malignancy; the 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer
Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
Current or previous other malignancy within 2 years of study entry without sponsor approval
History of another malignancy within 2 years prior to starting study treatment
History (within 2 years prior to first study drug administration) of another malignancy unless the malignancy was treated with curative intent and likelihood of relapse is small (<5% in 2 years in the judgment of the investigator).
Patients with a completely treated prior malignancy with no evidence of disease for ?3 years are eligible
Active malignancy other than SCLC within the previous 5 years
History of another malignancy within the previous 5 years;
History of previous systemic chemotherapy unless given curatively for other malignancy now > 5 years without evidence of recurrence
Research participants with presence of other active malignancy within 2 years of study entry; participants with history of prior malignancy treated with curative intent who achieved complete remission (CR) more than 2 years before study entry are eligible; this exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer
Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years prior to Step 2 registration; if the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
Participants has a history of hematological malignancy within the last 5 years prior to study entry
Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration; if the original histologic proof of malignancy is greater than 5 years, then pathological confirmation is required (e.g. from extra- or intra-cranial disease)
Patients who have received chemotherapy for a malignancy in the past 5 years
Another malignancy within 3 years
history of any other primary malignancy diagnosed within the past 5 years
Any other current or previous malignancy within the past 5 years
Patient has an active malignancy of metastatic potential other than the known NE tumor for the past 3 years
History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years
Has history of other active malignancy within 3 years prior to enrollment, except:
Has a history of a previous additional malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
Criteria 5, History of other malignancy within the past 5 years prior to enrollment with some exceptions, as outlined in the protocol.
History of other malignancy within the past 3 years