Clinical Phase II, Randomized, Double Blind Trial, to Evaluate the Efficacy of Metformin and Chemotherapy Versus Placebo Nad Chemotherapy in Neoadjuvant Setting for Locally Advanced Breast Cancer
Definitions Luminal A: tumors ER + PR + HER2 Negative and Ki67 <14% Luminal B: tumors ER
+/-, PR +/-, HER2 negative and Ki67 >15% Complete pathologic response is defined as the
abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is
considered as pCR
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
pathologic complete response
to assess the efficacy in terms of pahtologic complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy based on Paclitaxel followed by FAC, combined with metformin or placebo
pCR will be assesed after 24 weeks of treatment
No
Claudia Arce, MD, MSc
Principal Investigator
Instituto Nacional Canerologia
Mexico: Federal Commission for Protection Against Health Risks
MET-INCAN-1
NCT01566799
April 2012
April 2014
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