Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer, confirmed by true-cut or open biopsy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-Doxorubicin-Paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer|
- Pathological response rate
- Overall response rate (complete + partial responses)
- Conservative surgery rate
- Disease-free survival
- Tissue molecular markers and correlation with response
- XPD single nucleotide polymorphisms (SNPs) and correlation with treatment response
|Study Start Date:||December 2002|
|Estimated Study Completion Date:||August 2005|
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%.
|Spanish Breast Cancer Research Group|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Study Chair:||Antonio Antón, Md., PhD.||Spanish Breast Cancer Research Group (GEICAM)|
|Study Chair:||Pedro Sánchez-Rovira, MD., PhD||Spanish Breast Cancer Research Group (GEICAM)|