Choosing Neoadjuvant Chemotherapy Versus Hormonal Therapy for Breast Cancer Based on Gene Expression Profile

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