Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer
This study has been completed.
Information provided by (Responsible Party):
Lund University Hospital
First received: December 30, 2008
Last updated: April 12, 2012
Last verified: March 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.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Assessments of apoptosis using immunohistochemistry. [ Time Frame: After two weeks of treatment with statin therapy. ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Women with primary breast cancer who are candidates for radical surgery.
- Breast tumours clinically ≥ 15 mm, Nx, M0.
- Breast tumours identified on mammography and verified on fine needle aspiration.
- Age > 18 years.
- Performance status of ECOG ≤ 1.
- Laboratory requirements at the day of diagnosis (t1-):Prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
- Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Negative pregnancy test for pre menopausal women before inclusion in the trial
- Ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
- Prior breast cancer treatment.
- Current HRT.
- Known liver disease.
- History of hemorrhagic stroke.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
- History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816244
|University Hospital, Department of Oncology
|Lund, Sweden, 221 85 |
Lund University Hospital
||Carsten Rose, MD
||University Hospital Lund
No publications provided
||Lund University Hospital
History of Changes
|Other Study ID Numbers:
||MAST1, EudraCT number: 2008-005863-32
|Study First Received:
||December 30, 2008
||April 12, 2012
||Sweden: Medical Products Agency
Keywords provided by Lund University Hospital:
Cell cycle regulators
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Neoplasms by Site
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents