A Phase 2 Study of Neoadjuvant Chemotherapy With Sequential Weekly Nanoparticle Albumin Bound Paclitaxel (Abraxane) Followed by 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) in Locally Advanced Breast Cancer
This is a Phase 2, non-randomized study of neoadjuvant treatment with nanoparticle albumin
bound paclitaxel (Abraxane) every week for 12 weeks followed by 5-FU, epirubicin, and
cyclophosphamide (FEC) every 3 weeks for 4 cycles in women with locally advanced breast
cancer. Patients with HER-2 overexpressing breast cancer may receive trastuzumab
concurrently with the chemotherapy at the discretion of the investigator. The primary aim
of this study is to determine the pathologic complete response rate (pCR) of this sequential
Patients who achieve clinical complete response (cCR), clinical partial response (cPR), or
have resectable stable disease (SD) will undergo surgery. Surgery will consist of modified
radical mastectomy or excision of the primary tumor site with clear surgical margins
accompanied by axillary staging. Tumor samples taken prior to initiation of treatment will
be analyzed for molecular and genetic changes which will be correlated with tumor response.
Patients must have a histologically confirmed diagnosis of breast cancer without documented
evidence of distant metastatic disease. Patients with clinical Stage IIB (T3N0 only), IIIA,
or IIIB breast cancer will be potential candidates for this trial.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
pathologic complete response rate in the breast for patients with locally advanced breast cancer (LABC) who receive Abraxane
pCR examined in breast tissue taken at surgery
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Food and Drug Administration
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