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Tracking Information | |||||
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First Received Date † | June 7, 2006 | ||||
Last Updated Date | May 7, 2009 | ||||
Start Date † | March 2006 | ||||
Current Primary Outcome Measures † |
Change in a panel of biomarkers (high-sensitivity C-reactive protein [hsCRP], lipid profile, circulating estrogens, and contralateral breast density) from baseline [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00334542 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Simvastatin in Preventing a New Breast Cancer in Women Who Are at High Risk for a New Breast Cancer After Undergoing Surgery for Ductal Carcinoma in Situ or Stage I, Stage II, or Stage III Breast Cancer | ||||
Official Title † | A Phase II Study of Simvastatin in Women at High Risk for a New Breast Cancer | ||||
Brief Summary | RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin may keep cancer from coming back in women who are at high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer. PURPOSE: This phase II trial is studying how well simvastatin works in preventing a new breast cancer in women at high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to menopausal status (pre- vs post-menopausal). Patients receive oral simvastatin once daily for 24-28 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline and at the end of study treatment for pharmacogenetic and biomarker correlative studies. Patients undergo mammography and measurement of breast density of the contralateral breast at baseline and at the end of study treatment. Quality of life is assessed at baseline and at the end of study treatment. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Open Label | ||||
Condition † | Breast Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 50 | ||||
Completion Date | |||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00334542 | ||||
Responsible Party | Vered Stearns, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||
Secondary IDs †† | JHOC-J0485, JHOC-SKCCC-J0485, JHOC-04100404 | ||||
Study Sponsor † | Sidney Kimmel Comprehensive Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | March 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |