Clinical trial · Interventional
Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer
A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study
NCT00816244CI-TRIAL-00006714completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Postmenopausal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Atorvastatin
- interventionNames
- Drug: Atorvastatin
Primary outcomes (1)
- measure
- 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.
- timeFrame
- After two weeks of treatment with statin therapy.
Secondary outcomes (1)
- measure
- Assessments of apoptosis using immunohistochemistry.
- timeFrame
- After two weeks of treatment with statin therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (2)
- DERIVEDFeldt M, Menard J, Rosendahl AH, Lettiero B, Bendahl PO, Belting M, Borgquist S. The effect of statin treatment on intratumoral cholesterol levels and LDL receptor expression: a window-of-opportunity breast cancer trial. Cancer Metab. 2020 Nov 23;8(1):25. doi: 10.1186/s40170-020-00231-8. PMID 33292612
- DERIVEDFeldt M, Bjarnadottir O, Kimbung S, Jirstrom K, Bendahl PO, Veerla S, Grabau D, Hedenfalk I, Borgquist S. Statin-induced anti-proliferative effects via cyclin D1 and p27 in a window-of-opportunity breast cancer trial. J Transl Med. 2015 Apr 29;13:133. doi: 10.1186/s12967-015-0486-0. PMID 25925673