Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: anastrozole; Procedure: adjuvant therapy

• Registration Number: NCT00244959
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.

PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the 12-month change in breast density in postmenopausal women with ductal carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant anastrozole.

Secondary

* Determine the change in estrone sulfate levels in patients treated with this drug.

* Correlate the change in breast density with the change in circulating estrone sulfate levels in patients treated with this drug.

* Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the relationship between wild-type aromatase enzyme with change in breast density and change in estrone sulfate levels in patients treated with this drug.

* Determine the 12-month change in bone density, and correlate it with the change in circulating estrone sulfate levels in patients treated with this drug.

* Correlate the reversal of hypermethylation with change in circulating estrone sulfate levels and breast density in patients treated with this drug.

OUTLINE: This is a pilot study. Patients are stratified according to concurrent bisphosphonate use (yes vs no).

Patients receive oral anastrozole once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-27
• Primary Completion: 2007-09
• Study Completion: 2011-11
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anastrozole	anastrozole	Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
Anastrozole	adjuvant therapy	Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer

Primary Outcome Measures

Name	Time	Method
Change in breast density after 12 months of treatment	12 months

Secondary Outcome Measures

Name	Time	Method
Change in hormone levels after 12 months of treatment	12 months
Comparison between change in breast density with change in hormone levels after 12 months of treatment	12 months
Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment	12 months
Comparison between change in bone density with change in hormone levels after 12 months of treatment	12 months
Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment	12 months

Trial Locations

Locations (1)

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