LY353381 in Preventing Breast Cancer in Women With Hyperplasia

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: arzoxifene; Drug: Placebo

• Registration Number: NCT00005879
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia.

PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.

Detailed Description

OBJECTIVES:

* Determine if LY353381 hydrochloride improves baseline cytology in women at high risk for breast cancer.

* Determine if this drug modulates other potential surrogate endpoint biomarkers or drug effect biomarkers.

* Determine if cytologic improvement is associated with initial presentation of the various stratification factors.

* Determine whether cytology is correlated with other potential surrogate endpoint biomarkers or drug effect biomarkers and whether change in cytology is correlated with change in the other biomarkers.

* Monitor the effects of this drug in terms of quality of life and women's health.

OUTLINE: This is a randomized, double-blind, multicenter study followed by an open-label study for both arms. Patients are stratified according to cytologic status (hyperplasia with atypia vs hyperplasia without atypia), mutation status (known carrier for BRCA1 or BRCA2 genes vs known not to be a carrier of mutant genes), menopausal status (premenopausal vs postmenopausal), estrogen-receptor status, and participating center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive oral LY353381 hydrochloride once daily for 6 months.

* Arm II: Patients receive oral placebo once daily for 6 months. Patients in both arms then receive oral LY353381 hydrochloride for an additional 6 months.

Quality of life is assessed at baseline and then at 6 and 12 months.

Patients are followed at 2 weeks and then annually for 5 years.

PROJECTED ACCRUAL: A total of 210-220 patients will be accrued for this study within 2.5-3 years.

Study Timeline

• Study First Submitted: 2000-06-02
• Study Start: 2000-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2017-01-23
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 199

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arzoxifene	arzoxifene	LY353381, 20 mg daily
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months	Baseline to 6 months	Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist.; Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia.
Change in Masood Score	Baseline to 6 months	Change in the semi-quantitative score assigned by the designated cytopathologist.; Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.

Trial Locations

Locations (2)

U.S. Oncology Research, Inc.; 🇺🇸 Dallas, Texas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States