Primary Outcome Measures:
- pathologic complete response rate in the breast for patients with locally advanced breast cancer (LABC) who receive Abraxane [ Time Frame: pCR examined in breast tissue taken at surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- pathologic complete response rate in the breast and axillary nodes (pCR breast and nodes) in all patients [ Time Frame: pCR examined in breast and lymph node tissue taken at surgery ] [ Designated as safety issue: No ]
- complete clinical response rate (cCR) of the sequential regimen in patients who present with palpable measurable disease [ Time Frame: physical exam between the two chemotherapy regimens and at completion of the entire treatment regimen ] [ Designated as safety issue: No ]
- complete clinical and imaging response rate (ciCR) of the sequential regimen in all patients [ Time Frame: physical exam and breast imaging at 3-4 weeks after the last chemotherapy treatment ] [ Designated as safety issue: No ]
- complete clinical response rate (cCR)of Abraxane in patients who present with palpable measurable disease [ Time Frame: physical exam at completion of the Abraxane portion of the treatment regimen ] [ Designated as safety issue: No ]
- toxicity of the sequential chemotherapy regimen [ Time Frame: during treatment and for 3 to 4 weeks after the last chemotherapy cycle ] [ Designated as safety issue: Yes ]
- toxicity of the sequential chemotherapy regimen when administered concurrently with trastuzumab [ Time Frame: during treatment and for 3 to 4 weeks after the last chemotherapy cycle ] [ Designated as safety issue: Yes ]
- 2-year progression-free survival [ Time Frame: from the first dose of study therapy to first date of disease progression or for a maximum of 24 months from study entry ] [ Designated as safety issue: No ]
- 2-year overall survival (OS) [ Time Frame: from the first dose of study therapy to date of death or for a maximum of 24 months from study entry ] [ Designated as safety issue: No ]
- exploration of molecular and genetic correlates of response [ Time Frame: after specimen procurement and continuing after completion of clinical phase of study ] [ Designated as safety issue: No ]
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 regimen.
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.