Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer

Inclusion Criteria: * Female patients aged 18 years or older * Histologically confirmed invasive unilateral breast cancer * HER2-negative disease * Known hormone receptor status (estrogen receptor \[ER\], progesterone receptor \[PgR\]), tumor grade and, if institutional standard permits, known Ki67 value * Available paraffin-embedded tumor block taken at diagnostic biopsy for central confirmation of HER2 eligibility, hormone receptor status, Ki67 value and biomarker evaluation is mandatory * One of the following clinical stages: * T2, T3, T4 disease, triple negative (HER2, ER, PgR) * T2, T3, T4 disease, ER or PgR positive and moderately differentiated or poorly differentiated tumor grade (G II-III) * ECOG performance status 0 or 1 * Written informed consent to participate in the trial (approved by the Institutional Review Board \[IRB\]/ Independent Ethics Committee \[IEC\]) obtained prior to any study specific screening procedures * Willing and able to comply with the protocol Exclusion Criteria: * Synchronous contralateral breast cancer or presence of metastatic disease (M1). Exception: contralateral insitu ductal cancer * Surgical axillary staging procedure prior to study entry. Exceptions: 1) Fine needle aspiration (FNA) of an axillary node is permitted for any patient, and 2) although not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted * Pregnant or lactating women. * Women with childbe…