Conditions: Breast Cancer
Keywords: breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 199
Healthy volunteers: yes

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.

Arms:
arm 1: Placebo arm 2: LY353381, 20 mg daily

Interventions: intervention 1: arzoxifene intervention 2: Placebo
Intervention descriptions: intervention 1: one tablet daily intervention 2: matched tablet dialy

Protocol document: