Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study|
- 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. ] [ Designated as safety issue: Yes ]
- Assessments of apoptosis using immunohistochemistry. [ Time Frame: After two weeks of treatment with statin therapy. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Atorvastatin 80 mg daily for two weeks, ending at the day of operation for breast cancer.
Blood samples and three core biopsies are taken after diagnosis. Treatment with atorvastatin at a daily dosis of 80 mg is initiated 14 days before planned surgery. Translational research will be performed from the core biopsy and blood samples taken before surgery and from the specimen from surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816244
|University Hospital, Department of Oncology|
|Lund, Sweden, 221 85|
|Principal Investigator:||Carsten Rose, MD||University Hospital Lund|