Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-Doxorubicin-Paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer
2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each
patient before breast surgery.
The required number of patients has been calculated following Simon’s method. 43 patients
will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2
pathological complete responses obtained. Patients recruitment will continue until 43
patients have been enrolled. Assumptions are that there is a 95% probability to obtain a
rate of pathological complete responses of at least 10%.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological response rate
Antonio Antón, Md., PhD.
Spanish Breast Cancer Research Group (GEICAM)
Spain: Spanish Agency of Medicines