MRI and Mammography before Surgery in Patients with Stage I-II Breast Cancer

Inclusion Criteria

• Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0); diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded; for patients enrolled after receipt and completion of neoadjuvant chemotherapy, the clinical stage must be determined based on pre-chemotherapy assessment
• Patients must have either: * Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry [IHC] staining) and HER-2 negative breast cancer OR * ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors * HER2 status will be determined per the 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines: ** HER2 is considered positive if a) there is IHC 3+ staining or b) positive using either single probe in situ hybridization (ISH) or dual probe ISH ** HER2 is considered negative if a) there is IHC 0 or 1+ staining or b) ISH negative using either single probe ISH or dual probe ISH * For patients enrolling after neoadjuvant therapy, the ER, PR, and HER2 markers are based on assessment prior to initiating neoadjuvant treatment
• No patients with previous ipsilateral or contralateral invasive breast cancer or ductal carcinoma in situ (DCIS)
• No patients with bilateral breast cancer
• No patients with known deleterious mutations in breast cancer (BRCA) genes
• No history of receiving endocrine therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures; these agents used previously as chemoprevention are allowed
• Patients receiving neoadjuvant chemotherapy or recently completed neoadjuvant chemotherapy and will undergo surgery within 6 weeks are eligible
• No patients scheduled to receive partial breast irradiation following breast conserving surgery
• Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram; women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial; for patients who have neoadjuvant therapy, eligibility for BCT is determined at completion of therapy; repeat mammogram +/- ultrasound (US) of the affected side only will be required at completion of neoadjuvant chemotherapy to determine eligibility for BCT
• No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed can be enrolled; for patients with multifocal or multicentric disease enrolled after completion of neoadjuvant chemotherapy, histologic confirmation of multifocality/multicentricity must have been completed before initiation of chemotherapy
• Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow): * No history of untreatable claustrophobia * No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) * No history of sickle cell disease * No contraindication to intravenous contrast administration * No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance * No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a serum creatinine level obtained within 28 days prior to registration * Weight lower than that allowable by the MRI table
• No prior MRI of study breast within the 12 months prior to registration
• Non-pregnant and non-lactating; patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration; perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential
• Signed study-specific informed consent prior to registration