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Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

Information source: Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Locally Advanced Malignant Neoplasm

Intervention: Metformin (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Instituto Nacional de Cancerologia de Mexico

Official(s) and/or principal investigator(s):
Claudia Arce, MD, MSc, Principal Investigator, Affiliation: Instituto Nacional Canerologia

Overall contact:
Claudia Arce, MD, MSc, Phone: +525556280400, Ext: 294, Email: haydee.arce96@gmail.com

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

Clinical Details

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

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

Primary outcome: pathologic complete response

Secondary outcome:

Safety analysis

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

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

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

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

Locations and Contacts

Claudia Arce, MD, MSc, Phone: +525556280400, Ext: 294, Email: haydee.arce96@gmail.com

Instituto Nacional Cancerologi, Mexico, Distrito Federal 14080, Mexico
Additional Information

Starting date: April 2012
Last updated: March 29, 2012

Page last updated: August 20, 2015

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