No prior systemic treatment for metastatic breast cancer
Prior malignancy, other than breast cancer, active within the last 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 years
Any number of prior therapies for metastatic breast cancer is allowed; patients with weakly estrogen receptor positive breast cancer who received any number of endocrine agents for metastatic breast cancer will also be eligible
Prior or concurrent use of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer, including any history of prior irradiation to the ipsilateral breast; additionally, the patient must not have had hormonal therapy for breast cancer treatment or for breast cancer prevention within 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 day study intervention period
Breast cancer patients
No prior chemotherapy or trastuzumab for treatment of metastatic breast cancer
Prior systemic therapy for treatment and prevention of breast cancer
Prior history of breast cancer.
Prior therapies for metastatic breast cancer\r\n* Frontline patients who have not received prior systemic therapy for metastatic breast cancer are eligible, \r\n* Patients who have received =< prior chemotherapy regimens for metastatic breast cancer are eligible
Women with metastatic breast cancer who are eligible for capecitabine monotherapy; for HER positive breast cancer, concurrent trastuzumab is allowed OR
Patients with metastatic breast cancer
At least one prior line of therapy for metastatic breast cancer
HER positive breast cancer
Patients who had received therapy for metastatic breast cancer (other than that described above)
Patients with new or progressive breast cancer metastatic to brain will be eligible provided:
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
Stage I-III non-metastatic breast cancer\r\n* Inflammatory breast cancer (Td) is acceptable\r\n* Patients with oligo-metastatic disease who are being treated with a curative intent as per the treating physician are eligible as well
Must have received no more than 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
Metastatic breast cancer
Previous history of breast cancer (even in the other breast)
Evidence of progressive breast cancer within the last days
Must have progressed on at least prior systemic therapy regimen for the treatment of advanced breast or other non-breast metastatic cancer; there is no upper limit on the number of prior therapies
Patients must have either A) histologic documentation of metastatic or locally advanced breast cancer by core needle or incisional biopsy, or B) history of breast cancer with radiologic evidence of bone-only metastatic disease
A prior, unrelated, breast cancer is allowed
Evidence of progressive breast cancer within the last days
Prior systemic therapy for the indexed breast cancer
Male breast cancer
Prior therapy for breast cancer
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
Subject has received more than prior line of chemotherapy treatment for metastatic breast cancer
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 years
Patients who have received prior lapatinib for metastatic breast cancer will be excluded
Prior treatment with at least two () HER-directed regimens for metastatic breast cancer.
Breast cancer must be HER-negative.
Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.
HER positive breast cancer
Have not previously received therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer
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 HER-negative breast cancer
Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ? days of tamoxifen or NSAI goserelin for advanced breast cancer prior to randomization.
HER-positive breast cancer
patients with breast cancer for whom FU chemotherapy is the standard treatment
Patients with biopsy-confirmed breast cancer
Patients with metastatic breast cancer
Patients with documented HER-positive metastatic disease are not eligible, even if their primary breast cancer was HER-negative
The cancer enhances on breast MRI imaging
Participants must have histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced; histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
=< days from the patients most recent breast surgery for this breast cancer
Evidence of metastatic breast cancer
HER-positive breast cancer confirmed by a central laboratory
HER-positive breast cancer
Patients who have received a previous HER breast cancer vaccine
=< days between the planned treatment start date and the patients most recent breast surgery for this breast cancer
Prior therapy for the treatment of breast cancer is not allowed
HER-positive breast cancer
No prior treatment for metastatic breast cancer
Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
Participants must have histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced; histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
Prior taxane therapy for metastatic breast cancer.
Subjects with prior history of cancer in the ILT treated breast
Part D: Breast cancer that is advanced and/or metastatic
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
Patients who have received prior chemotherapy for their original breast cancer treatment are still eligible
Breast cancer: Patients with Her- 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 [- days] before surgical resection of the primary breast tumor)
Any prior breast cancer
Patients with metastatic breast cancer
Breast cancer eligible for primary surgery
Breast cancer
Breast cancer
Histologically verified breast cancer with distant metastases (metastatic breast cancer)
Prior or concomitant treatment for advanced breast cancer.
For subjects with breast cancer:
No current evidence of breast cancer
Has received prior capecitabine treatment for advanced breast cancer
Has received more than prior antiangiogenic agent for breast cancer
Recurrent breast cancer or history of prior breast radiation therapy
Male breast cancer patients
Diagnosed with metastatic breast cancer, caregiver to patient with metastatic breast cancer (MBC) who is enrolled in this study, or MBC provider
Advanced or metastatic breast cancer
BREAST CANCER COHORT:
No prior therapy for current breast cancer
Patients with metastatic breast cancer
Metastatic breast cancer
History of recurrent breast cancer (with a prior history of chemotherapy)
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
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
Patients with metastatic breast cancer are not eligible to participate
History of prior breast cancer surgery
Breast cancer survivors
Breast cancer at age or below
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
Patients with metastatic breast cancer
Prior treatment of gynecologic or breast cancer with chemotherapy
Metastatic breast or other cancer
Metastatic breast or other cancer
Have completed curative treatment for breast cancer
Male breast cancer survivors
Have a history of breast cancer
No prior chemotherapeutic treatment for any malignancy other than breast cancer
Pathologic documentation of breast cancer
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
Have one male relative with breast cancer
Patients with known breast cancer
Patients who have had a lumpectomy for breast cancer within months prior to the study
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 >= .% over 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 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) or BRCA 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 or evidence of metastatic breast cancer
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 months prior to registration
Prior history or evidence of metastatic breast cancer
Women with history of surgical, medical, or radiation therapy for breast cancer
No prior history of breast cancer
High risk: this includes patients with any of the following:\r\n* >= % 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 or earlier\r\n* History of breast cancer with st or nd degree relative with breast cancer and either patient or relative diagnosed at 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
Females s/p treatment for breast cancer within last years
Patients who have received prior treatment for the current breast cancer
Serious systemic illness other than breast cancer
Women who have had a prior history of breast cancer in the same breast
The cancer enhances on breast MRI imaging
Any history of prior radiation or chemotherapy for breast cancer
For participants with breast cancer only:
Within weeks of a new line of breast cancer therapy and/or progression on scans and/or a change in current breast cancer therapy regimen
Patients who have had breast cancer previously
Histopathologically confirmed metastatic breast cancer