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Status:

COMPLETED

Simvastatin in Preventing a New Breast Cancer in Women at High Risk for a New Breast Cancer

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief 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...

Detailed Description

OBJECTIVES: Primary * Describe changes from baseline in a panel of biomarkers (high-sensitivity C-reactive protein \[hsCRP\], lipid profile, circulating estrogens, and contralateral breast density) ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2011

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00334542

    Start Date

    March 1 2006

    End Date

    November 1 2011

    Last Update

    April 3 2019

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231-2410

    2

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115-6084