Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

Locally Advanced Malignant Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01566799
• Other study ID #: MET-INCAN-1
• 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

• Breast Neoplasms
• Locally Advanced Malignant Neoplasm
• Neoplasms

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