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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 Other: pharmacological study Procedure: adjuvant therapy |
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 | |
Baltimore, Maryland, United States, 21231-2410 |
Principal Investigator: | Vered Stearns, MD | Sidney Kimmel Comprehensive Cancer Center |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Vered Stearns ) |
Study ID Numbers: | CDR0000485361, JHOC-J05100, JHOC-SKCCC-J05100 |
Study First Received: | July 19, 2006 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00354640 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Antimetabolites Anastrozole Antineoplastic Agents, Hormonal Skin Diseases Simvastatin Antilipemic Agents Adjuvants, Immunologic Breast Neoplasms Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Carcinoma Carcinoma, Ductal Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Aromatase Inhibitors Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |
Antimetabolites Anastrozole Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms by Site Carcinoma in Situ Therapeutic Uses Aromatase Inhibitors Breast Diseases Neoplasms by Histologic Type Skin Diseases Antineoplastic Agents, Hormonal Simvastatin |
Antilipemic Agents Breast Neoplasms Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Carcinoma Neoplasms Carcinoma, Intraductal, Noninfiltrating Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Neoplasms, Glandular and Epithelial |