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Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

This study is not yet open for participant recruitment.
Verified March 2012 by Instituto Nacional de Cancerologia de Mexico
Sponsor:
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Claudia Arce Salinas, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01566799
First received: March 22, 2012
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  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 Intervention Phase
Locally Advanced Malignant Neoplasm
 Drug: Metformin
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

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


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


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Metformin
metformin 500 mg/day po for 24 weeks.
Other Name: Dabex

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566799

Contacts
Contact: Claudia Arce, MD, MSc +525556280400 ext 294 haydee.arce96@gmail.com
Contact: Julieta Santamaria, Nurse +525556280400 ext 116 ztinala@yahoo.es

Locations
Mexico
Instituto Nacional Cancerologi
Mexico, Distrito Federal, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Claudia Arce, MD, MSc Instituto Nacional Canerologia
  More Information

No publications provided

Responsible Party: Claudia Arce Salinas, Medico Especialista, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01566799     History of Changes
Other Study ID Numbers: MET-INCAN-1
Study First Received: March 22, 2012
Last Updated: March 29, 2012
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Locally advanced breast cancer
Neoadjuvant chemotherapy
Metformin
Pathologic Complete Response

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013