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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00354640 |
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
PURPOSE: This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: anastrozole Drug: simvastatin Procedure: adjuvant therapy Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole |
Estimated Enrollment: | 20 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Patients continue to receive oral anastrozole once daily (as prior to study entry). They also receive oral simvastatin once daily for 14-18 days in the absence of unacceptable toxicity or diagnosis of new or recurrent breast cancer.
Patients undergo blood sample collection at baseline and after study therapy for analysis of anastrozole and hormone (estradiol and estrogen) concentrations.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets any of the following criteria:
PATIENT CHARACTERISTICS:
No daily alcohol use of > 3 standard drinks/day
PRIOR CONCURRENT THERAPY:
No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5 years
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Principal Investigator: | Vered Stearns, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000485361, JHOC-J05100, JHOC-SKCCC-J05100 |
Study First Received: | July 19, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00354640 |
Health Authority: | Unspecified |
breast cancer breast cancer in situ ductal breast carcinoma in situ stage I breast cancer |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Carcinoma, Ductal Anastrozole Skin Diseases Simvastatin Carcinoma in Situ Breast Neoplasms |
Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Ductal, Lobular, and Medullary Aromatase Inhibitors |