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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00637481 |
Purpose
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of atorvastatin may prevent breast cancer.
PURPOSE: This randomized phase I trial is studying the best dose of atorvastatin in preventing breast cancer in women at increased risk for breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Atorvastatin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer |
| Estimated Enrollment: | 66 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: No Intervention
Group 1 will not receive any atorvastatin.
|
|
|
Group 2: Experimental
10 mg atorvastatin every day
|
Drug: Atorvastatin
Group 2 = 10 mg atorvastatin every day Group 3 = 20 mg atorvastatin every day Group 4 = 40 mg atorvastatin every day |
|
Group 3: Experimental
20 mg atorvastatin every day
|
Drug: Atorvastatin
Group 2 = 10 mg atorvastatin every day Group 3 = 20 mg atorvastatin every day Group 4 = 40 mg atorvastatin every day |
|
Group 4: Experimental
40 mg atorvastatin every day
|
Drug: Atorvastatin
Group 2 = 10 mg atorvastatin every day Group 3 = 20 mg atorvastatin every day Group 4 = 40 mg atorvastatin every day |
OBJECTIVES:
Primary
Secondary
OUTLINE: Participants are randomized to 1 of 4 arms.
Eligibility| Ages Eligible for Study: | 18 Years to 72 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center 713-792-3245 | |
| Principal Investigator: | Banu Arun, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Banu Arun, MD / Professor ) |
| Study ID Numbers: | 2006-0185, CDR0000588191, MDA-MDA05-6-01, MDA-2006-0185 |
| Study First Received: | March 17, 2008 |
| Last Updated: | December 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00637481 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
precancerous/nonmalignant condition breast cancer ductal breast carcinoma in situ lobular breast carcinoma in situ atypical ductal breast hyperplasia |
|
Antimetabolites Skin Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Breast Neoplasms Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases Atorvastatin |