New diagnosis of DCIS without invasive cancer; date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS
No previous history of breast cancer (DCIS or invasive cancer) in either breast prior to current DCIS diagnosis
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)
DCIS or Stage I-III primary invasive carcinoma of the breast
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
High grade and/or invasive and/or carcinoma in situ disease
INCLUSION - ENROLLMENT: Diagnosis of invasive ductal carcinoma
Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast
Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast
Multicentric gross breast carcinoma (either DCIS or invasive cancer) or microscopic breast carcinoma occupying a volume with maximum dimensions of more than 3 centimeters
Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast; biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis
Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast\r\n* Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis
Previously untreated breast cancer determined by a core needle biopsy showing invasive ductal carcinoma or invasive lobular carcinoma
Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimeters
Multifocal or multicentric invasive breast carcinoma
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)
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
Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters
Current diagnosis of invasive or inflammatory breast carcinoma
Previously untreated breast cancer determined by a core needle biopsy showing invasive ductal carcinoma or invasive lobular carcinoma
Multicentric invasive or in situ carcinoma
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
Multicentric carcinoma (DCIS or invasive)
No prior surgical excision in the index breast for current DCIS diagnosis of DCIS
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
Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer
Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
Proven multicentric carcinoma (DCIS or invasive) in more than one quadrant or separated by 4 or more centimeters or diffuse (> 1 quadrant) suspicious calcifications
Patients may have had prior non-invasive (ductal carcinoma in situ [DCIS]) cancer if there has been no recurrence; prior ipsilateral invasive cancer also allowed if more than 5 years previous
Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ
Core biopsy should definitively demonstrate invasive carcinoma
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
Diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)
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
New diagnosis of invasive carcinoma
Personal history and/or concomitant diagnosis of invasive breast cancer or DCIS
Core needle biopsy positive for invasive breast cancer or ductal breast carcinoma in situ (DCIS)
Previous surgery for DCIS or invasive 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)
Patient must have a tissue diagnosis of invasive breast carcinoma
Patient's most recent surgery was wide local excision with or without re-excision and for which there was obtained clear (>= 2 mm) margins at breast conserving surgery, and the pathology reveals pure DCIS; patients with invasive cancer or DCIS with microinvasion will not be registered on step 3, but will be followed for clinical outcomes\r\n* NOTE: if resection is documented to have reached pectoral fascia and deep margin is free but less than 2 mm, the patient is eligible\r\n* NOTE: if no residual DCIS is found on wide local excision as it was fully removed in core biopsy, the patient is eligible\r\n* NOTE: patients with lobular carcinoma in situ (LCIS) as well as DCIS are eligible
Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
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.
Malignancies other than urothelial cancer (UC) within 5 years prior to cycle 1, day 1, with the exception of those with a low risk of metastasis or death treated with expected curative outcome (such as, but not limited to, adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent and absence of PSA relapse, or ductal carcinoma in situ of the breast treated surgically with curative intent) or incidental prostate cancer (T1a, Gleason score =< 6 and PSA < 0.5 ng/mL)
Malignancies other than the disease under study within 5 years prior to start of study treatment, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc).
Malignancies other than the disease under study within 3 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or low-risk prostate cancer undergoing active surveillance; patients on androgen deprivation therapy as part of adjuvant therapy after radiation for prostate cancer will be allowed
Malignancies other than the disease under study within 5 years prior to study treatment, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0)
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)
Malignancies other than urothelial cancer within 5 years prior to cycle 1 day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (T1/T2a, Gleason score =< 3 + 4, and PSA =< 0.5 ng/mL undergoing active surveillance and treatment naive)
Malignancies other than pancreatic cancer ?5 years prior to Minnelide cycle 1 day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcomes (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer or ductal carcinoma in situ treated surgically with curative intent) or localised prostate cancer treated with curative intent and absence of PSA relapse or incidental prostate cancer (Gleason score ?3 +4 and PSA <10ng/L undergoing active surveillance and treatment naïve).
Malignancies other than the disease under study =< 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc)
Malignancies other than RCC within 5 years of first study treatment with the exception of those with negligible risk of metastases or death and/or treated with expected curative outcome (carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma)
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score ? 6, and prostate-specific antigen [PSA] ? 10 mg/mL, etc.)
Diagnosis of any second malignancy within the last 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death, per investigator’s discretion (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
Malignancies other than rectal cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
Patients who have known additional malignancies other than UBC within 2 years before initiation of study treatment; exceptions include malignancies with a negligible risk of metastasis or death and treated with expected curative outcome (e.g., non–melanomatous skin cancers), or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)
Malignancies other than colorectal adenocarcinoma within 5 years prior to treatment, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)
Malignancies other than disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia [CLL] Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0)
Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ? 6, and prostate-specific antigen [PSA] ? 10 mg/mL, etc.) Medication-Related Exclusion Criteria:
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g. prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc)
Malignancies within 3 years prior to treatment start, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia [CLL] Rai stage 0, prostate cancer with Gleason score =< 6, and prostate specific antigen [PSA] =< 10 mg/mL, etc.)
Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
Malignancies other than the disease under study within 3 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard of care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score ? 6, and prostate-specific antigen [PSA] ? 10 mg/mL, etc.)
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g. prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc)
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)
Malignancies other than SCLC within 2 years prior to administration of study treatment with the exception of those with a negligible risk of metastases or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or breast, basal or squamous cell skin cancer, or localized prostate cancer treated definitively)
Malignancies other than metastatic colorectal cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)
Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
Malignancies other than CRC within 5 years prior to randomization, except for those with a minimal risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ treated surgically with curative intent
Malignancies other than urothelial cancer (UC) within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent and absence of PSA relapse, or ductal carcinoma in situ of the breast treated surgically with curative intent) or incidental prostate cancer\r\n* Patients are considered to be free of active malignancy if they have completed therapy and have a < 30% risk of relapse
Malignancies other than pancreatic carcinoma within 2 years prior to study start, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) Exclusion Criteria Related to Medications
Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g. prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc)
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
Curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy
Presence of lobular carcinoma
History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed >5 years prior to diagnosis of current breast cancer
Prior cancer diagnosis except the following:\r\n* Squamous cell cancer of the skin without known metastasis\r\n* Basal cell cancer of the skin without known metastasis\r\n* Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS])\r\n* Carcinoma in situ of the cervix
Prior cancer diagnosis, unless the patient has been disease free for >= 3 years, with the following exceptions:\r\n* Squamous cell cancer of the skin without known metastasis\r\n* Basal cell cancer of the skin without known metastasis\r\n* Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS])\r\n* Carcinoma in situ of the cervix
Patients must be disease-free of prior invasive malignancies for >= 2 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix (for phase II only); patients with the following prior or concurrent diagnoses are eligible: lobular carcinoma in situ, contralateral ductal carcinoma in situ, or contralateral invasive ductal and/or lobular cancer (and no prior adjuvant chemotherapy for previous breast malignancy)
Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
Evidence of active malignancy (other than current NSCLC, non-melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, localized/stable renal masses, ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS) of the breast, or localized and presumed cured prostate cancer) within the last 3 years
Subjects must not have invasive lobular carcinoma
Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
Patients must be disease-free of prior invasive malignancies for >= 2 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix; patient with the following prior concurrent diagnoses are eligible: lobular carcinoma in situ, contralateral ductal carcinoma in situ, or contralateral invasive ductal and/or lobular carcinoma
Active malignancy requiring treatment other than ALL within two years prior to start of treatment, with the exception of basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, localized prostate cancer, or ductal breast carcinoma in situ (DCIS) or lobular breast carcinoma in situ (LCIS) of the breast
Prior history of other malignancy with the exclusion of localized prostate cancer, non-melanomatous skin cancer, ductal carcinoma or lobular carcinoma in situ of the breast
Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])
Lobular or mixed ductal and lobular histology
Patients with lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma
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).
Women scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-III (including ductal carcinoma in situ), or prophylaxis (BRCA1/2 mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected)
Participants who have another cancer diagnosis, except that the following diagnoses will be allowed:\r\n* Squamous cell cancer of the skin without known metastasis; note, patients with suspected cutaneous squamous cell carcinomas (cuSCCs) should have them excised prior to study registration\r\n* Basal cell cancer of the skin without known metastasis\r\n* Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS])\r\n* Carcinoma in situ of the cervix\r\n* Any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 3 years
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
In situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphoma
History of previous invasive breast cancer =< 5 years\r\n* NOTE: history of DCIS, lobular carcinoma in situ (LCIS) is allowed
Participants with a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are not allowed to enter the study if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast (they are allowed to enter the study if treated with surgery alone)
History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
Prior cancer diagnosis except that the following: \r\n* Squamous cell cancer of the skin without known metastasis\r\n* Basal cell cancer of the skin without known metastasis\r\n* Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS])\r\n* Carcinoma in situ of the cervix\r\n* Any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 years
Subjects with lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phylloides tumor, or Paget's disease
Patients with invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphoma
Participants with a history of previous breast cancer are excluded, with the exception of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ?5 years ago. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years are excluded.
History of breast cancer (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the current diagnosis
Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and \NOS\ (not otherwise specified); invasive lobular cancer is excluded
Prior history of invasive breast cancer (patients with a history of DCIS or lobular carcinoma in situ [LCIS] are eligible)
Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast
Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); in-situ disease alone is not allowed
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
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)
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
The participant has a 5-year breast cancer risk 1.67% or lifetime risk of 20% according to the Gail model; or has a prior diagnosis of lobular carcinoma in situ (LCIS)
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
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
Diagnosis of: invasive breast cancer (stage I-III), ductal carcinoma in situ, lobular carcinoma in situ, lobular carcinoma
Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
Have had a prior biopsy diagnosed atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years; or have had multiple prior breast biopsies, regardless of histology
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)
Prior lobular carcinoma in situ (LCIS) is allowed
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 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
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%
At high risk of developing breast cancer (history of ductal carcinoma in situ [DCIS], lobular carcinoma in situ [LCIS], atypical ductal hyperplasia [ADH], Gail 5 year risk > 1.66% or lifetime risk > 20%)
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)
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
Diagnosis of lobular carcinoma in situ (LCIS), atypical ductal, or lobular hyperplasia.
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)
A prior biopsy indicating proliferative breast disease, atypical hyperplasia, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
Prior history of ipsilateral breast cancer (DCIS, LCIS [lobular cancer in situ] or invasive)
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
Patients with invasive lobular carcinoma
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)
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
No prior malignancy of any type (including ductal breast carcinoma in situ [DCIS]) within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with a prior history of breast cancer greater than 5 years from study screening may participate in this study
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
Curatively treated ductal carcinoma in situ of the breast.
History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancer
Adequately treated breast ductal carcinoma in situ
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
INCLUSION - TREATMENT: Pathologic review shows no evidence of residual disease in the tumor bed (to also include no evidence of residual ductal carcinoma in situ [DCIS])
Histologically confirmed invasive carcinoma or ductal carcinoma in situ (DCIS) of the breast
For the window phase: Patients must have histologically confirmed invasive lobular carcinoma or invasive ductal carcinoma; no central confirmation of histological subtype is necessary for enrollment; patients with mixed invasive ductal and lobular carcinoma are eligible and will be stratified as ductal
Patients with a history of ipsilateral or contralateral ductal carcinoma in situ (DCIS) are eligible
Adequately treated breast ductal carcinoma in situ without evidence of disease
Ductal breast carcinoma in situ (DCIS) only
Ductal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous [colloid], or tubular histologies)
Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy
Clinical T1N0M0 invasive carcinoma or ductal carcinoma in situ (DCIS) < or equal to 2 cm
Ductal carcinoma in-situ with microinvasions (T1mic)
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)
Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).
On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast
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
Breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
Ductal carcinoma in-situ or invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed
Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS)
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
On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma
The participant has breast biopsy consistent with ductal carcinoma in situ (DCIS)
Adequately treated breast ductal carcinoma in situ without evidence of disease
Subjects with ductal carcinoma in situ (DCIS)  that express HER-2 on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or needle-localized (NL) surgical biopsy with positive margins
Grade 1-3 invasive ductal, mammary, mucinous, tubular, colloidal, or pure ductal carcinoma in situ (DCIS) measuring =< 2.5 cm on final pathology (the tumor should be clinical stage T1N0M0 in patients electing brachytherapy in whom the catheter will be placed intraoperatively)
Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
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
Ductal carcinoma in situ (DCIS) or invasive ductal, medullary, papillary, mucinous (colloid), or tubular histologies
Pathologic T stage of Tis, T1, or T2 with total size of tumor =< 3 cm (this size criteria applies to both pure ductal carcinoma in situ [DCIS] and invasive tumors)
ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or
Synchronous bilateral breast cancer (invasive or ductal carcinoma in situ [DCIS])
Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast
Curatively treated ductal carcinoma in situ of the breast;
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
Patients must have a tissue diagnosis of low, intermediate or high grade ductal carcinoma in situ or ductal carcinoma in situ with microinvasion.
Patients with ductal carcinoma in situ undergoing either lumpectomy/radiation or mastectomy.
Diagnosis of ductal carcinoma in situ (DCIS) or stage I, II, or III breast cancer
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
Ductal carcinoma in situ (DCIS) diagnosis
Ambulatory outpatients with breast (including ductal carcinoma in situ [DCIS]) cancer
Presence of a proportion of ductal carcinoma in situ (DCIS) in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Invasive or ductal carcinoma in situ (DCIS) breast cancer
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
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
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
History of prior ductal carcinoma in situ (DCIS) treated within the past two years; patients completing all treatment for a previous diagnosis of DCIS over two years prior to the current diagnosis are eligible
Histologically confirmed invasive breast cancer or Ductal Carcinoma In Situ (DCIS)
History of any of the following:\r\n* Invasive breast cancer\r\n* Ductal breast carcinoma in situ (DCIS)\r\n* Flat epithelial atypia
DCIS or previous invasive ductal carcinoma.
Positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer
Any personal history of cancer, including ductal carcinoma in situ (DCIS) and not including non-melanoma skin cancers
Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
History of prior breast cancer, ductal carcinoma in situ
No patients with previous ipsilateral or contralateral invasive breast cancer or ductal carcinoma in situ (DCIS)
No or equivocal ER testing performed prior to surgery if biopsy indicates ductal carcinoma in situ
History of other malignancy in the past 2 years except non-melanomatous skin cancer, breast ductal carcinoma in situ (DCIS) and low-risk prostate adenocarcinoma
History of other malignancy in the past 2 years except non-melanomatous skin cancer, breast ductal carcinoma in situ (DCIS) and low-risk prostate adenocarcinoma
Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).
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)
Ductal carcinoma in situ
A primary diagnosis of stage 0 (ductal carcinoma in situ), 1, 2, or 3a breast cancer
Patients must not have received any prior radiation to the bladder for bladder cancer
Prior bladder-directed radiotherapy.
Participant has a history of bladder cancer (including in situ bladder cancer)
Diagnosis of superficial bladder cancer
Evidence of bladder perforation during diagnostic cystoscopy.
Prior therapeutic radiation to the bladder
Superficial bladder tumors (Ta, Tis, T1) OR
Patient with a history of previous bladder cancer:
Patient has a tumor in the bladder diverticulum
Patient must undergo TraceIT hydrogel placement within 8 weeks prior to starting radiation therapy for bladder cancer
Treatment for metastatic bladder cancer
Has a tumor in a bladder diverticulum
Not have a prior history of non-bladder cancer unless the cancer is clinically stable
History of bladder cancer
superficial bladder cancer;
Evidence of > 7 tumors present in the bladder
Have suspected or known invasive (>= T1) bladder cancer
Have non-invasive (< T1) bladder cancer
History of, or active bladder cancer
BLADDER: Histological documentation of urothelial cancer either on outside transurethral bladder biopsy or on initial transurethral bladder biopsy at MD Anderson under PA13-0291
Non-invasive, superficial bladder cancer.
Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
Patients must have an adequately functioning bladder after thorough evaluation by a urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible
Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions
Current systemic therapy for bladder cancer
Bladder Cancer
Prior radiation therapy to the bladder
Severe neurogenic bladder
Untreated bladder stones
Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
Histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed histology bladder cancer
Non-invasive, superficial bladder cancer.
Bladder cancer
Prior radiation therapy to the bladder
Patient has a tumor in a bladder diverticulum.
Prior radiation therapy to the bladder
Patients with hydronephrosis secondary to bladder cancer
functional bladder problems defined as IPSS > 19;
current bladder cancer, urethral stricture, or bladder neck contracture; a cystoscopy my be performed at the investigator's discretion to rule out these conditions;
Bladder capacity of less than 200 ml
Prior radiation therapy to the bladder
Part B: Have a diagnosis of bladder cancer.
Non-invasive, superficial bladder cancer.
Controlled, superficial bladder carcinoma
Presence of a single bladder tumor lesion
Have a history of bladder neck contracture,
Diagnosis of bladder cancer
History of diagnosis of neurogenic bladder.
Grade G1 - G3 bladder cancer
Currently being treated or scheduled to have radiation treatment for bladder cancer during the study
Currently being treated with or having been treated in the last 12 months with any investigational drug for high risk superficial bladder cancer
Scheduled to have surgery for bladder cancer during the study
Bladder cancer
Clinical diagnosis of bladder cancer
Patient with known bladder cancer
Bladder cancer (current or prior)
Superficial bladder tumors (Ta, Tis, T1) OR
Patients who have bladder tumors of stage >= T3; or
Patients who have had cystectomies for bladder cancer; or
Have a history of invasive (>= T1) bladder cancer
Bladder cancer (current or prior)
Operable invasive breast cancer
Invasive lobular cancer
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
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)
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
All patients must be diagnosed with invasive breast cancer
Histologically confirmed invasive lobular breast cancer, that is hormone receptor-positive and HER2-negative, measuring at least 1 centimeter (cm) radiographically or clinically, clinical stages I-III; invasive lobular histology will be diagnosed at the enrolling institution for purposes of study participation; subsequently, invasive lobular histology will be confirmed by central pathology review, but this central review will not be required prior to patient enrollment
Prior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registration
Prior investigational drugs or interventions for invasive breast cancer treatment within 6 months before registration are not allowed; prior participation in window-of-opportunity trials without therapeutic intent is allowed if intervention is no more than 3 weeks in duration
Prior history of invasive breast cancer
Have had or are planning to have the following invasive procedures:
Histologic or clinical evidence of invasive breast cancer
Patients with any active invasive cancer are not eligible
No prior systemic therapy or radiotherapy for currently-diagnosed invasive or noninvasive breast cancer
Prior systemic therapy for invasive or non-invasive (DCIS) breast cancer
Bilateral invasive breast cancer
Has invasive breast cancer; this does not include microinvasion
No prior history of an invasive breast cancer
Synchronous bilateral invasive or non-invasive breast cancer
Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS within 1 month
Any suspicion for invasive cancer
Second invasive melanoma
Synchronous bilateral invasive or non-invasive breast cancer
Have had or are planning to have the following invasive procedures:
Biopsy confirmed multifocal, multicentric, or contralateral disease that is invasive or non-invasive
Histologic or cytologic confirmation of invasive breast cancer that is HER2-negative by standard clinical criteria
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
Prior history of DCIS or invasive breast cancer
Synchronous bilateral invasive or non-invasive breast cancer
Synchronous bilateral invasive breast cancer
Known invasive breast cancer of any type
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)
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.
No prior history of non-breast invasive malignancies in the past 1 year
History of invasive breast cancer prior to the current diagnosis
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 with a history of previous invasive breast cancer
Any stage invasive breast cancer provided the primary breast tumor size is >= 1 cm
History of another “active” invasive primary cancer requiring ongoing treatment
The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
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
History of prior invasive or in situ cancer in either breast
Women with non-invasive disease or microinvasion are not eligible
Participants must have a confirmed or suspected invasive or non-invasive bladder tumor (initial or recurrent) discovered on cystoscopy or radiologic imaging performed within 120 days of randomization
Initial core biopsy showing invasive lobular cancer
EGFR GERMLINE MUTATION TESTING: One of the following criteria:\r\n* Personal history of invasive lung cancer or one of the pre-invasive histologies associated with the development of lung cancer (adenocarcinoma in situ [AIS], minimally invasive adenocarcinomas [MIA] or atypical adenomatous hyperplasia [AAH]) and more than two affected family members with invasive lung cancer or one of the pre-invasive histologies associated with the development of lung cancer; OR\r\n* First-degree relatives of an individual enrolled in the study with a known EGFR germline mutation
Any prior treatment for the current primary invasive breast cancer
Bilateral invasive breast cancer
Bilateral invasive breast cancer.
Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
Any prior treatment for primary invasive breast cancer
Bilateral invasive, multicentric, or metastatic breast cancer
Use of minimally invasive surgery.
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
Ever had a diagnosis of invasive or microinvasive breast cancer
Diagnosis of any invasive gynecologic cancer without evidence of disease
Elective minimally invasive operation
The patient must have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy
Surgical margins are negative for invasive or non-invasive breast cancer
Diagnosed with operable invasive cancer
No history of invasive cervical cancer
Invasive breast cancer; areas of microinvasion or suspicious for microinvasion on the core biopsy is allowed
No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator; diagnosis of invasive cancer must be at least 5 years prior to initiation on trial
Any current invasive cancer diagnosis
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
Prior colon cancer (>= 3 years out from invasive cancer)
Diagnosed with a first primary invasive ER+ breast cancer (stages I-IIIa)
Prior excisional biopsy of the primary invasive breast cancer
Subject has invasive lobular cancer
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
Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed)
No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator
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
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.
Pathological diagnosis of invasive adenocarcinoma of the breast
Patients undergoing a partial mastectomy OR mastectomy for the treatment of an invasive or non-invasive breast malignancy
Have been diagnosed with a HER2+ invasive cancer of the breast
Patient has concurrent invasive bilateral breast malignancies or multicentric disease
Patient is scheduled for brain surgery and/or another invasive procedure within the time period of one month prior to 18F-FSPG administration. Minimally invasive needle biopsies are allowed.
Patients diagnosed with unilateral DCIS or invasive breast cancer
Patients with invasive, inflammatory breast cancer or distant metastases will be excluded from participating in this study
Patient must have a histologic diagnosis of invasive breast cancer
Prior invasive breast cancer, prior mastectomy or breast radiation within 12 months
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 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
Diagnosis of invasive 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:
Confirmed current or past diagnosis of invasive breast cancer