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