Phase II study of neoadjuvant gemcitabine, epirubicin, and albumin-bound nab paclitaxel (GEA) in locally advanced breast cancer with SPARC tumor assessments

603 Background: Gemcitabine (G), anthracyclines and taxanes have significant activity as neoadjuvant therapy. SPARC, a known prognostic factor for poor survival, is an albumin binding protein that may mediate intratumoral accumulation of nab-paclitaxel (nab-pac) via a SPARC-albumin specific binding activity. This study investigated SPARC tumor status with pathologic correlatives and responses to neoadjuvant chemotherapy. Methods: Eligibility: Clinical T1c-T4-d and/or N0–3, M0 breast cancer (T1N0M0 excluded). ER/PR/HER2 status were obtained for all pts. ECOG PS 0–2, normal LVEF, Treatment: 6 cycles neoadjuvant G 2,000 mg/m2, epirubicin 50 mg/m2, and nab-pac 175 mg/m2 q14 days followed by surgery. Postoperative therapy: 4 cycles G 2,000 mg/m2 and nab-pac 220 mg/m2 q14 days. Myeloid growth factors were mandated with all cycles. Tumor SPARC immunohistochemistry was scored on a 0–3 scale (0=absent, 1= weak, 2=moderate, 3=strong). Fisher's exact test was used for statistical analyses. Results: 123 pts have enro...