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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 ongoing, but not recruiting participants.
First Received: July 19, 2006   Last Updated: March 31, 2009   History of Changes
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
Other: pharmacological study
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole

Resource links provided by NLM:


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
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Vered Stearns )
Study ID Numbers: CDR0000485361, JHOC-J05100, JHOC-SKCCC-J05100
Study First Received: July 19, 2006
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00354640     History of Changes
Health Authority: United States: Federal Government

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:
Antimetabolites
Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Simvastatin
Antilipemic Agents
Adjuvants, Immunologic
Breast Neoplasms
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Carcinoma
Carcinoma, Ductal
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Aromatase Inhibitors
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anastrozole
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms by Site
Carcinoma in Situ
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases
Neoplasms by Histologic Type
Skin Diseases
Antineoplastic Agents, Hormonal
Simvastatin
Antilipemic Agents
Breast Neoplasms
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009