NCT01566799

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 22, 2012

Last Update Submit

March 29, 2012

Conditions

Locally Advanced Malignant Neoplasm

Keywords

Locally advanced breast cancerNeoadjuvant chemotherapyMetforminPathologic Complete Response

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Safety analysis

    after 24 treatment weeks'

  • Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy

    after 24 treatment weeks'

  • To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response

    safter 24 treatment weeks'

Study Arms (1)

Metformin

EXPERIMENTAL

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

Interventions

MetforminDRUG

metformin 500 mg/day po for 24 weeks.

Also known as: Dabex
Metformin

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional Cancerologi

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Pathologic Complete Response

Interventions

Metformin

Condition Hierarchy (Ancestors)

Disease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Claudia Arce, MD, MSc

    Instituto Nacional Canerologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Arce, MD, MSc

CONTACT

+525556280400haydee.arce96@gmail.com

Julieta Santamaria, Nurse

CONTACT

+525556280400ztinala@yahoo.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medico Especialista

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 29, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2014

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

ME(1)