NCT00083174

Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer

A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,560 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen. PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.

Detailed description

OBJECTIVES: Primary Previously: To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo. Currently: To determine the frequency of serious adverse events for post-menopausal women at high-risk of developing breast cancer who choose to receive 5 years of exemestane as preventative therapy. Secondary Previously: (same as is currently listed in PDQ) Currently: To address the Trial Committee and Sponsor's commitment to allow women who are randomized to the MAP.3 trial to receive 5 years of exemestane therapy. OUTLINE: This study was a randomized, double-blind, placebo-controlled, multicentre study. Protocol-specified analyses were performed in April 2011. The results of these analyses are posted in the Results section. Following the amendment of May 2011, the study is now open-label and all eligible patients are receiving exemestane from participating sites for a total of 5 years. After exemestane is stopped, there is no further follow-up. PROJECTED ACCRUAL:There were 4560 women from the United States, Canada, Spain and France who took part in this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	exemestane	one 25 mg tablet daily in am

Timeline

• Start date: 2004-12-03
• Primary completion: 2011-03-25
• Completion: 2018-01-22
• First posted: 2004-05-17
• Last updated: 2023-08-25
• Results posted: 2013-05-20

Locations

76 sites across 4 countries: United States, Canada, France, Puerto Rico

Regulatory

• FDA-regulated drug study