The purpose of this study is to learn how breast cancer tumors respond to a drug called Abraxane followed by a combination of 3 chemotherapy drugs commonly used for 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 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Nanoparticle albumin bound paclitaxel 100 mg/m2 IV for 30 minutes once weekly for 12 weeks followed by FEC (5-FU 500mg/m2 IV push; epirubicin 100 mg/m2 IV over 15 min. \[or if given with trastuzumab 75 mg/m2 IV over 15 min.\]; cyclophosphamide 500 mg/m2 IV over 30 min.) on Day 1 every 21 days
NSABP Operations Center
Pittsburgh, Pennsylvania, United States
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
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
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
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
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
toxicity of the sequential chemotherapy regimen
Time frame: during treatment and for 3 to 4 weeks after the last chemotherapy cycle
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
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
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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
exploration of molecular and genetic correlates of response
Time frame: after specimen procurement and continuing after completion of clinical phase of study