(-) The impact of obesity and obesity treatments on breast cancer (clinicaltrials.gov) - Jan 9, 2012 - P1, N=24; Active, not recruiting; Completion date: Jul '12 -> Jul '13
Completion date • Breast Cancer • Renal Cell Carcinoma
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This study is ongoing, but not recruiting participants.
First Received on July 3, 2009. Last Updated on January 6, 2012 History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party): M.D. Anderson Cancer Center ( M.D. Anderson Cancer Center )
ClinicalTrials.gov Identifier: NCT00933309
Purpose
The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body.
Condition Intervention Phase
Breast Cancer
Drug: Exemestane
Drug: Avandamet
Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Obesity and Obesity Treatments on Breast Cancer: A Phase I Trial of Exemestane With Metformin and Rosiglitazone for Postmenopausal Obese Women With ER+ Metastatic Breast Cancer
Resource links provided by NLM:
Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Obesity
Drug Information available for: Exemestane Rosiglitazone Rosiglitazone Maleate Avandamet Metformin Metformin hydrochloride
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
Dose-limiting toxicity (DLT) [ Time Frame: Day 1 of each cycle ] [ Designated as safety issue: No ]
Estimated Enrollment: 24
Study Start Date: July 2009
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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