Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer, A Collaborative Trial
This is a single-arm, open-label phase II study of cyclophosphamide and docetaxel/taxotere
(TC) every 3 weeks in Her2 (-) subjects with locally advanced breast cancer. It is designed
to assess (1) the clinical and pathologic response rates to this regimen, as well as its
tolerability in this subject population, and (2) the expression of Tiam1 in tumor-associated
fibroblasts pre and post treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response Rate
The primary outcome measure for this study is the complete response rate for evaluable participants on neoadjuvant chemotherapy with cyclophosphamide and docetaxel. A clinical complete response (cCR) is defined as resolution of all palpable masses.
3-4 weeks post-surgery
John S Nystrom, MD
Tufts Medical Center
United States: Federal Government