Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer
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|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|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|