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Simvastatin and Anastrozole in Treating Postmenopausal Women With Invasive Breast Cancer, Ductal Carcinoma In Situ, or a High Risk of Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2007
Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00354640
  Purpose

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.

PURPOSE: This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: simvastatin
Procedure: adjuvant therapy
Procedure: pharmacological study
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Anastrozole Simvastatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage change in blood concentrations of anastrozole at 14 days [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent reduction of serum estradiol levels at 14 days [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2006
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Assess the effects of concurrent anastrozole and simvastatin on anastrozole's steady-state concentration in postmenopausal women with history of invasive breast cancer or ductal carcinoma in situ or at high risk for developing breast cancer.

Secondary

  • Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in these patients.

OUTLINE: This is a pilot study.

Patients continue to receive oral anastrozole once daily (as prior to study entry). They also receive oral simvastatin once daily for 14-18 days in the absence of unacceptable toxicity or diagnosis of new or recurrent breast cancer.

Patients undergo blood sample collection at baseline and after study therapy for analysis of anastrozole and hormone (estradiol and estrogen) concentrations.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Meets any of the following criteria:

    • History of invasive breast cancer
    • History of ductal carcinoma in situ
    • At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer
  • Receiving anastrozole for ≥ 30 days as adjuvant breast cancer treatment or for prevention of breast cancer
  • No active breast cancer with known metastatic involvement
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal
  • ECOG performance status 0-2
  • AST and ALT ≤ 3 times upper limit of normal
  • Creatinine clearance ≥ 30 mL/min
  • No active liver disease
  • No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components
  • No daily alcohol use of > 3 standard drinks/day

    • A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No cholesterol-lowering drug, including a statin, within the past 3 months
  • No selective estrogen receptor modulator (SERM) within the past 3 months
  • No other hormone therapy within the past 3 months
  • No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5 years

    • Vaginal estrogen preparations allowed
  • No other concurrent statin or cholesterol-lowering drug
  • No other concurrent SERM
  • No other concurrent hormone therapy
  • No other concurrent investigational drugs
  • No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine
  • No concurrent chemotherapy or biological agents
  • No concurrent daily grapefruit juice > 8 oz/day
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354640

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000485361, JHOC-J05100, JHOC-SKCCC-J05100
Study First Received: July 19, 2006
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00354640  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer
breast cancer in situ
ductal breast carcinoma in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:
Carcinoma, Ductal
Anastrozole
Skin Diseases
Simvastatin
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Ductal, Lobular, and Medullary
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009