Clinical trial · Interventional
Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer
NCT00416403CI-TRIAL-00008671completedPhase 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)
RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer. PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Surgery Only - Arm III | Procedure | — | UNRESOLVED |
| fluvastatin sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: fluvastatin sodium
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral fluvastatin sodium as in arm I at a higher dose.
- interventionNames
- Drug: fluvastatin sodium
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients do not receive fluvastatin sodium. breast Cancer surgery only
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ductal carcinoma in situ (DCIS) or stage I breast cancer by stereotactic core or incisional biopsy * Planning to undergo surgery in 3-6 weeks * Patients undergoing re-excision due to evidence of tumor present at surgical margins are eligible * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * ALT and AST ≤ 10% above upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to tolerate statins * Willing to undergo 2 blood draws (separated by approximately 3-4 weeks) during study participation (control arm) PRIOR CONCURRENT THERAPY: * No other concurrent statins * No concurrent chemotherapy * No concurrent administration of any of the following: * Niacin * Propranolol * Cholestyramine * Cyclosporine * Digoxin * Erythromycin * Itraconazole * Gemfibrozil * Phenytoin * Diclofenac * Tolbutamide * Glyburide * Losartan * Cimetidine * Ranitidine * Omeprazole * Rifampin * Warfarin * No initiation of new hormonal therapy during study participation * Concurrent participation in other clinical trials (e.g., for DCIS or prevention) is allowed
References
Publications (1)
- RESULTGarwood ER, Kumar AS, Baehner FL, Moore DH, Au A, Hylton N, Flowers CI, Garber J, Lesnikoski BA, Hwang ES, Olopade O, Port ER, Campbell M, Esserman LJ. Fluvastatin reduces proliferation and increases apoptosis in women with high grade breast cancer. Breast Cancer Res Treat. 2010 Jan;119(1):137-44. doi: 10.1007/s10549-009-0507-x. PMID 19728082