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 institutional review board (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 Eastern Cooperative Oncology Group Score (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 (MRI or ultrasound) within 6 weeks prior to randomization; If indicated for abnormal lymph nodes, fine needle aspirate (FNA) or core biopsy must be performed.
• The tumor must have been determined to be HER2-negative as follows:
• Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to Chromosome 17 centromere (CEP17) must be 10% tumor staining by immunohistochemistry
• The patient must have been evaluated by a treating physician, reviewed and discussed by the multi-disciplinary breast team, and considered to be a candidate for chemotherapy

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 registration
• 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 ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (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 registration
• 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 registration