Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: anastrozole; Drug: simvastatin; Other: pharmacological study; Procedure: adjuvant therapy

• Registration Number: NCT00354640
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Study First Posted: 2006-07-20
• Primary Completion: 2008-10
• Study Completion: 2011-11
• Results First Submitted: 2013-03-18
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-15
• Last Update Submitted: 2013-05-15
• Results First Posted: 2013-06-24
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anastrozole and Simvastatin	pharmacological study	This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
Anastrozole and Simvastatin	adjuvant therapy	This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
Anastrozole and Simvastatin	anastrozole	This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
Anastrozole and Simvastatin	simvastatin	This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.

Primary Outcome Measures

Name	Time	Method
Change in Blood Concentrations	Baseline and 14 days	The change in blood concentrations of anastrozole at baseline and 14 days was measured.

Secondary Outcome Measures

Name	Time	Method
Change in Serum Estradiol Levels	Baseline and 14 days	The change in serum concentrations of estradiol at baseline and 14 days was measured.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States