Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- pathologic complete response [ Time Frame: pCR will be assesed after 24 weeks of treatment ] [ Designated as safety issue: No ]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
- Safety analysis [ Time Frame: after 24 treatment weeks' ] [ Designated as safety issue: Yes ]For safety analysis we are going to use NCTC criteria version 3.0
- Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy [ Time Frame: after 24 treatment weeks' ] [ Designated as safety issue: No ]tumor measurements by caliper every cycle and by ultrasound at the end of chemotherapy
- To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response [ Time Frame: safter 24 treatment weeks' ] [ Designated as safety issue: No ]correlation between serum levels of insuline levels, HbA1 and PCR and PCR
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Patients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o.
metformin 500 mg/day po for 24 weeks.
Other Name: Dabex
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
|Contact: Claudia Arce, MD, MSc||+525556280400 ext email@example.com|
|Contact: Julieta Santamaria, Nurse||+525556280400 ext firstname.lastname@example.org|
|Instituto Nacional Cancerologi|
|Mexico, Distrito Federal, Mexico, 14080|
|Principal Investigator:||Claudia Arce, MD, MSc||Instituto Nacional Canerologia|