Arzoxifene or Tamoxifen in Preventing Breast Cancer in Premenopausal Women at High Risk for Breast Cancer

Breast Cancer Clinical Trial

Official title: A Phase II Study of a Selective Estrogen Receptor Modulator (LY353381) vs. Tamoxifen vs. Placebo in Premenopausal Women With and Increased Risk for Breast Cancer

Status Completed

Clinical Trial Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using arzoxifene or tamoxifen may prevent breast cancer by lowering the amount of estrogen the body makes. The use of arzoxifene or tamoxifen may keep breast cancer from forming in women at high risk for breast cancer.

PURPOSE: This randomized phase II trial is studying arzoxifene to see how well it works compared to tamoxifen or a placebo in preventing breast cancer in premenopausal women at high risk for breast cancer.

Clinical Trial Description

OBJECTIVES:

• Compare the effect of arzoxifene vs tamoxifen vs placebo on surrogate endpoints biomarkers, especially systemic insulin-like growth factor levels, in women at high risk for breast cancer.

• Compare the toxic effects, biologic effects, clinical pharmacology, and pharmacodynamics of these drugs in these participants.

• Determine the effect of these drugs on surrogate endpoint biomarkers in participants with BRCA1 and BRCA2 mutations.

• Determine the feasibility of a chemoprevention study in participants with a strong family history of breast cancer.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Participants are randomized to 1 of 3 treatment arms.

• Arm I: Participants receive oral tamoxifen once daily.

• Arm II: Participants receive oral arzoxifene once daily.

• Arm III: Participants receive an oral placebo once daily. In all arms, treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. After the completion of 6 months of treatment, participants are offered the opportunity to continue treatment with their assigned study drug for an additional 6 months. Participants randomized to receive placebo are offered treatment with arzoxifene for an additional 6 months.

After completion of study treatment, participants are followed annually.

PROJECTED ACCRUAL: A total of 120 participants will be accrued for this study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hereditary Breast/Ovarian Cancer (brca1, brca2)
• Ovarian Neoplasms

• NCT number: NCT00253539
• Study type: Interventional
• Source: The Cleveland Clinic
• Status: Completed
• Phase: Phase 2
• Start date: January 2002
• Completion date: April 2005