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A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole



- 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.


- 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.

Inclusion Criteria


- 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


- 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


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Blood Concentrations

Outcome Description:

The change in blood concentrations of anastrozole at baseline and 14 days was measured.

Outcome Time Frame:

Baseline and 14 days

Safety Issue:


Principal Investigator

Vered Stearns, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:

J05100, CDR0000485361



Start Date:

June 2006

Completion Date:

November 2011

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410