Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer
Status:
Unknown status
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
Background Obesity and overweight are well known risk factors for breast cancer and also are
associated with higher recurrence and mortality rates.
Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms
of pathologic complete response in comparison with placebo plus the same chemotherapy regimen
Design: Randomized, double blind, clinical trial. This study will be performed at National
Cancer Institute of Mexico City, at breast cancer unit.
Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate.
After completion of chemotherapy all patients will have a breast surgery to assess pathologic
response.
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
Phase:
Phase 2
Details
Lead Sponsor:
Instituto Nacional de Cancerologia de Mexico
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran