Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer
|ClinicalTrials.gov Identifier: NCT00816244|
Recruitment Status : Completed
First Posted : January 1, 2009
Last Update Posted : April 13, 2012
The purpose of this study is to monitor:
- Tumor biological alterations following two weeks of neo-adjuvant statin therapy.
- Effects of statins on tumor proliferation.
- Functional studies on the mevalonate pathway.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Postmenopausal||Drug: Atorvastatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study|
|Study Start Date :||January 2009|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
U.S. FDA Resources
Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.
- Tumor biological alterations following two weeks of neo-adjuvant statin therapy in postmenopausal breast cancer patients; to evaluate the tumor proliferation using Ki67 as proliferation marker. [ Time Frame: After two weeks of treatment with statin therapy. ]
- Assessments of apoptosis using immunohistochemistry. [ Time Frame: After two weeks of treatment with statin therapy. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816244
|University Hospital, Department of Oncology|
|Lund, Sweden, 221 85|
|Principal Investigator:||Carsten Rose, MD||University Hospital Lund|