Trial | NCT01566799  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
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
Study Started
Apr 30
2012
Primary Completion
Apr 30
2013
Anticipated
Study Completion
Apr 30
2014
Anticipated
Last Update
Mar 30
2012
Estimate

Drug Metformin

metformin 500 mg/day po for 24 weeks.

  • Other names: Dabex

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.

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
No Results Posted