Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer
Status:
Completed
Trial end date:
2014-05-15
Target enrollment:
Participant gender:
Summary
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%.