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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Susan G. Komen Breast Cancer Foundation |
| Information provided by (Responsible Party): | 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 |
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Exemestane alone
|
Drug: Exemestane
25 mg tablets orally once a day
Other Name: Aromasin®
|
|
Experimental: Group 2
Exemestane plus Avandamet
|
Drug: Exemestane
25 mg tablets orally once a day
Other Name: Aromasin®
Drug: Avandamet
Beginning dose 2 mg rosiglitazone with 500 mg metformin hydrochloride (2mg/500 mg) tablets taken orally once a day
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Francisco J. Esteva, MD, PhD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00933309 History of Changes |
| Other Study ID Numbers: | 2008-0284 |
| Study First Received: | July 3, 2009 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Breast Obese Obesity Treatment Exemestane Aromasin |
Metformin and Rosiglitazone Avandamet Postmenopausal Hormone-sensitive Hormone-receptive-positive breast cancer |
|
Breast Neoplasms Obesity Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
Rosiglitazone Metformin Exemestane Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |