Phase 2
N=50
Simvastatin in Preventing a New Breast Cancer in Women at High Risk for a New Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00334542 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline — -0.15; -54; -1; -81.5 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- simvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline |
-0.15; -54; -1; -81.5 | — |
| PRIMARY Change in a Panel of Biomarkers (Contralateral Breast Density) From Baseline |
-0.78 | — |
| SECONDARY Prevalence of Breast Gene (Estrogen Receptor [ER]-α and ER-β, Cyclin D2, RAR-β, Twist, RASSF1A, and HIN-1) Hypermethylation |
0.5; 0; 0.21; 0; -0.08; 0.01 | — |
| SECONDARY Prevalence of Akt and p-Akt Activation by Contralateral Core Breast Biopsies |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00334542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.