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 analysisAssess 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
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