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Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

NCT01566799 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-03-30

No results posted yet for this study

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

Conditions

  • Locally Advanced Malignant Neoplasm

Interventions

DRUG

Metformin

metformin 500 mg/day po for 24 weeks.

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    collaborator OTHER

  • Instituto Nacional de Cancerologia de Mexico

    lead OTHER

Principal Investigators

  • Claudia Arce, MD, MSc · Instituto Nacional Canerologia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-04-30
Completion
2014-04-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566799 on ClinicalTrials.gov