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Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

NCT ID: NCT01566799

Last Updated: 2012-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-04-30

Brief Summary

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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

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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

Conditions

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Locally Advanced Malignant Neoplasm

Keywords

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Locally advanced breast cancer Neoadjuvant chemotherapy Metformin Pathologic Complete Response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Metformin

Patients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

metformin 500 mg/day po for 24 weeks.

Interventions

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Metformin

metformin 500 mg/day po for 24 weeks.

Intervention Type DRUG

Other Intervention Names

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Dabex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role collaborator

Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role lead

Responsible Party

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Claudia Arce Salinas

Medico Especialista

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Arce, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional Canerologia

Locations

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Instituto Nacional Cancerologi

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Central Contacts

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Claudia Arce, MD, MSc

Role: CONTACT

Phone: +525556280400

Email: [email protected]

Julieta Santamaria, Nurse

Role: CONTACT

Phone: +525556280400

Email: [email protected]

Other Identifiers

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MET-INCAN-1

Identifier Type: -

Identifier Source: org_study_id