Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer | RxWiki

Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

Overview[ - collapse ][ - ]

Purpose	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
Condition	Locally Advanced Malignant Neoplasm
Intervention	Drug: Metformin
Phase	Phase 2
Sponsor	Instituto Nacional de Cancerologia de Mexico
Responsible Party	Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier	NCT01566799
First Received	March 22, 2012
Last Updated	March 29, 2012
Last verified	March 2012

Tracking Information[ + expand ][ + ]

First Received Date	March 22, 2012
Last Updated Date	March 29, 2012
Start Date	April 2012
Estimated Primary Completion Date	April 2014
Current Primary Outcome Measures	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
Current Secondary Outcome Measures	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

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer
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
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 Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Locally Advanced Malignant Neoplasm
Intervention	Drug: Metformin metformin 500 mg/day po for 24 weeks. Other Names: Dabex
Study Arm (s)	Experimental: Metformin Patients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	60
Estimated Completion Date	April 2014
Estimated Primary Completion Date	April 2013
Eligibility Criteria	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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Claudia Arce, MD, MSc +525556280400 haydee.arce96@gmail.com
Location Countries	Mexico

Administrative Information[ + expand ][ + ]

NCT Number	NCT01566799
Other Study ID Numbers	MET-INCAN-1
Has Data Monitoring Committee	Yes
Information Provided By	Instituto Nacional de Cancerologia de Mexico
Study Sponsor	Instituto Nacional de Cancerologia de Mexico
Collaborators	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators	Principal Investigator: Claudia Arce, MD, MSc Instituto Nacional Canerologia
Verification Date	March 2012

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