At a glance
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A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Chemotherapy Regimens With Weekly Paclitaxel or Eribulin Followed by Doxorubicin and Cyclophosphamide in Women With Locally Advanced HER2-Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Eribulin, and 2 other interventions for Breast Cancer and HER2-negative Breast Cancer. Completed, enrolled 50 participants across 20 sites in 2 countries.
Detailed Summary
NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary aim of the study is to determine the pathologic complete response (ypCR) in breast and axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant regimens.
Study Details
Timeline
Interventions
80 mg/m2 IV over 60 minutes weekly for 12 weeks
1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles