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Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Instituto Nacional de Cancerologia de Mexico.
Recruitment status was  Not yet recruiting
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

March 22, 2012
March 29, 2012
April 2012
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01566799 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer
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

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

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Locally Advanced Malignant Neoplasm
Drug: Metformin
metformin 500 mg/day po for 24 weeks.
Other Name: Dabex
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.
Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
April 2014
April 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact: Claudia Arce, MD, MSc +525556280400 ext 294 haydee.arce96@gmail.com
Contact: Julieta Santamaria, Nurse +525556280400 ext 116 ztinala@yahoo.es
Mexico
 
NCT01566799
MET-INCAN-1
Yes
Claudia Arce Salinas, Instituto Nacional de Cancerologia de Mexico
Instituto Nacional de Cancerologia de Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Principal Investigator: Claudia Arce, MD, MSc Instituto Nacional Canerologia
Instituto Nacional de Cancerologia de Mexico
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP