Clinical trial · Interventional
Simvastatin in Preventing a New Breast Cancer in Women at High Risk for a New Breast Cancer
A Phase II Study of Simvastatin in Women at High Risk for a New Breast Cancer
NCT00334542CI-TRIAL-00037916completedPhase 2Results postedClinicalTrials.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: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin may keep cancer from coming back in women who are at high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer. PURPOSE: This phase II trial is studying how well simvastatin works in preventing a new breast cancer in women at high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or stage I, stage II, or stage III 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Simvastatin
- description
- Simvastatin 40 mg for 24-28 weeks
- interventionNames
- Drug: simvastatin
Primary outcomes (2)
- measure
- Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline
- timeFrame
- Baseline and week 24
- measure
- Change in a Panel of Biomarkers (Contralateral Breast Density) From Baseline
- timeFrame
- Baseline and week 24
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * History of histologically confirmed breast cancer, meeting 1 of the following staging criteria: * Ductal carcinoma in situ * Stage I-III invasive breast cancer * At least 3 months since completion of all intended local and systemic therapy, including mastectomy or lumpectomy with or without radiotherapy, adjuvant chemotherapy, and/or endocrine therapy * May have declined recommended treatment provided all treatment intended/agreed upon by the patient and treating physician was completed ≥ 3 months ago * At least 1 healthy intact breast * No prior radiotherapy or mastectomy * Prior biopsies allowed * Any hormone-receptor status PATIENT CHARACTERISTICS: * Female * Pre- or post-menopausal * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception * No active liver disease * AST and ALT ≤ 3 times upper limit of normal * Creatinine clearance ≥ 30 mL/min * No prior hypersensitivity to any 3-hydroxyl-3-methylglutaryl-Coenzyme A (HMG-CoA) reductase inhibitor or any of its components * No other concurrent infectious, inflammatory, or autoimmune diseases (at the discretion of principal investigator) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No daily alcohol use \> 3 standard drinks per day * Standard drink defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor * No selective estrogen receptor modulator or aromatase inhibitor within the past 3 months * No hormone replacement therapy (HRT) within the past 3 months * No prior estrogen and/or progesterone HRT ≥ 5 years in duration * Vaginal estrogen preparations allowed * No concurrent HRT * No other cholesterol-lowering drug, including a statin, within the past 3 months * No concurrent itraconazole, ketoconazole, nefazodone, cyclosporine, HIV protease inhibitors, clarithromycin, erythromycin, mibefradil, carbamazepine, bosentan, chaparral, amiodarone, or verapamil * No concurrent daily grapefruit juice consumption \> 8 ounces per day * No other concurrent agents or therapies intended to treat or prevent in situ or invasive breast cancer
References
Publications (2)
- BACKGROUNDFackler MJ, McVeigh M, Mehrotra J, Blum MA, Lange J, Lapides A, Garrett E, Argani P, Sukumar S. Quantitative multiplex methylation-specific PCR assay for the detection of promoter hypermethylation in multiple genes in breast cancer. Cancer Res. 2004 Jul 1;64(13):4442-52. doi: 10.1158/0008-5472.CAN-03-3341. PMID 15231653
- RESULTHiggins MJ, Prowell TM, Blackford AL, Byrne C, Khouri NF, Slater SA, Jeter SC, Armstrong DK, Davidson NE, Emens LA, Fetting JH, Powers PP, Wolff AC, Green H, Thibert JN, Rae JM, Folkerd E, Dowsett M, Blumenthal RS, Garber JE, Stearns V. A short-term biomarker modulation study of simvastatin in women at increased risk of a new breast cancer. Breast Cancer Res Treat. 2012 Feb;131(3):915-24. doi: 10.1007/s10549-011-1858-7. Epub 2011 Nov 11. PMID 22076478