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Clinical Trials/NCT00244959
NCT00244959CompletedPhase 2

Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country54 target enrollmentStarted: January 2004Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
54
Locations
1
Primary Endpoint
Change in breast density after 12 months of treatment
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Anastrozole

Experimental

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

Intervention: anastrozole (Drug)

Anastrozole

Experimental

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

Intervention: adjuvant therapy (Procedure)

Outcomes

Primary Outcomes

Change in breast density after 12 months of treatment

Time Frame: 12 months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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