Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

Phase 2

• Conditions: Locally Advanced Malignant Neoplasm
• Interventions: Drug: Metformin

• Registration Number: NCT01566799
• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico

Brief 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

Detailed 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

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Last Update Submitted: 2012-03-29
• Last Update Posted: 2012-03-30
• Study Start: 2012-04
• Primary Completion: 2013-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

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Exclusion Criteria

• Previous use of metformin for any indication
• Presence of Diabetes Mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Patients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o.

Primary Outcome Measures

Name	Time	Method
pathologic complete response	pCR will be assesed after 24 weeks of treatment	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

Secondary Outcome Measures

Name	Time	Method
Safety analysis	after 24 treatment weeks'	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	after 24 treatment weeks'	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	safter 24 treatment weeks'	correlation between serum levels of insuline levels, HbA1 and PCR and PCR

Trial Locations

Locations (1)

Instituto Nacional Cancerologi; 🇲🇽 Mexico, Distrito Federal, Mexico