In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.
See above brief summary
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks
Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10
Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)
Bridgeport Hospital
Bridgeport, Connecticut, United States
Yale Smilow Cancer Center
New Haven, Connecticut, United States
Rhode Island Hsopital
Providence, Rhode Island, United States
Women and Infants
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Pathological Complete Response Rates at Surgery
Time frame: at surgery approximately 5 months after initial treatment
Number of Participants With Adverse Events
Measure of safety and tolerability according to CTCAE version 3.0
Time frame: 2 years
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