Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer

Inclusion Criteria:

• The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy - The patient must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines
• The patient must be female
• The patient must be greater than or equal to 18 years old
• The patient must have an ECOG performance status of 0 or 1
• The diagnosis of invasive carcinoma of the breast must have been made by core needle biopsy
• The primary breast tumor must be >= 2 cm by physical exam or imaging
• Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram + MRI and/or ultrasound) and, if indicated, by FNA or core biopsy within 6 weeks prior to randomization; If palpable nodes appear normal on imaging, fine needle aspirate (FNA) and core biopsy are not required
• The tumor must have been determined to be HER2-negative as follows: fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to CEP17 must be < 2.2) or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus; or if CISH is performed, the result must indicate a HER2 gene copy number of < 6 per nucleus; or immunohistochemistry (IHC) 0-1+; or IHC 2+ and FISH-negative or CISH-negative
• The tumor must have been determined to be ER+ and/or progesterone positive (PgR+) defined as > 10% tumor staining by immunohistochemistry
• The patient must be considered by the treating medical oncologist to be medically able to tolerate standard cytotoxic chemotherapy regimens

Exclusion Criteria:

• FNA alone to diagnose the primary tumor
• Excisional biopsy or lumpectomy performed prior to randomization
• Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to randomization
• Tumors clinically staged as including inflammatory breast cancer
• Ipsilateral cN2b or cN3 disease; (patients with cN1 or cN2a disease are eligible)
• Definitive clinical or radiologic evidence of metastatic disease; (Note: chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 6 weeks prior to randomization)
• Synchronous or metachronous contralateral invasive breast cancer; (patients with synchronous and/or metachronous contralateral DCIS or LCIS are eligible)
• HER2 test result of IHC 3+, regardless of FISH results, if performed
• Any history of ipsilateral invasive breast cancer or ipsilateral DCIS if treated with radiation therapy (RT); (patients with synchronous or metachronous ipsilateral LCIS are eligible)
• History of non-breast malignancies, except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin, within 5 years prior to randomization
• Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to randomization
• Cardiac disease (history of and/or active disease) that would preclude the use of chemotherapy
• Pregnancy or lactation at the time of randomization; (Note: pregnancy testing must be performed within 2 weeks prior to randomization for women of childbearing potential)
• Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
• Use of any investigational product within 30 days prior to randomization