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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01566799
Other study ID # MET-INCAN-1
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received March 22, 2012
Last updated March 29, 2012
Start date April 2012
Est. completion date April 2014

Study information

Verified date March 2012
Source Instituto Nacional de Cancerologia de Mexico
Contact Claudia Arce, MD, MSc
Phone +525556280400
Email haydee.arce96@gmail.com
Is FDA regulated No
Health authority Mexico: Federal Commission for Protection Against Health Risks
Study type Interventional

Clinical Trial 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


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date April 2014
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Women older than 18 years old and younger than 70 years old

- Invasive breast cancer confirmed by core biopsy, any histology

- Tumor =2 cm and/or lymph node positive (proven by FNA)(T2-4b, N0-3, M0)

- Must have ER/PR positive and HER2 negative

- Must have full staging and extent disease and clinically and radiographically tumor measure

- Without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)

- Normal liver, kidney and blood tests

- Performance Status ECOG 0-2 o Karnofsky =70%

- Fasten glucose levels <125 mg/dl

- Signed consent

Exclusion Criteria:

- Previous use of metformin for any indication

- Presence of Diabetes Mellitus

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Metformin
metformin 500 mg/day po for 24 weeks.

Locations

Country Name City State
Mexico Instituto Nacional Cancerologi Mexico Distrito Federal

Sponsors (2)

Lead Sponsor Collaborator
Instituto Nacional de Cancerologia de Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Safety analysis For safety analysis we are going to use NCTC criteria version 3.0 after 24 treatment weeks' Yes
Secondary Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy tumor measurements by caliper every cycle and by ultrasound at the end of chemotherapy after 24 treatment weeks' No
Secondary To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response correlation between serum levels of insuline levels, HbA1 and PCR and PCR safter 24 treatment weeks' No
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