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

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: exemestane

Registration Number: NCT00083174

Lead Sponsor: NCIC Clinical Trials Group

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 4560

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exemestane	exemestane	one 25 mg tablet daily in am

Primary Outcome Measures

Name	Time	Method
Percentage of Women With Serious Adverse Events	5 years open-label extension period	Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.
Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)	Over randomization period of study (median follow-up 35 months)	Invasive breast cancer incidence was estimated from the breast cancer-free survival (BCFS) which was calculated for all women from the day of the randomization to the earliest date of diagnosis for invasive breast cancer. Women who died from other causes were censored at the time of death. If a woman did not develop an invasive breast cancer, or died, BCFS was censored on the date of the last day the woman was known alive (LKA), which was the latest of the date of assessment. Women who had breast cancer before study entry were also censored at the time of randomization.

Secondary Outcome Measures

Name	Time	Method
Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer	Over randomization period of study (median follow-up 35 months)	It was estimated from the Total Breast Cancer-Free Survival (TBCFS), which was calculated for women who developed invasive or non-invasive (DCIS) breast cancer as the time from the date of randomization to the earliest date of diagnosis for invasive or non-invasive (DCIS) breast cancer. Women who died from other causes were censored at the time of death. Women who had breast cancer before entry were censored at the time of randomization. If a woman did not develop an invasive or non-invasive (DCIS) breast cancer, or died, TBCFS will be censored on the date of last known alive.
Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events	Over randomization period of study (median follow-up 35 months)
Number of Clinical Breast Biopsies	Over randomization period of study (median follow-up 35 months)
Incidence of All Clinical Fractures	During protocol treatment over randomization period of study (up to 5 years)
Incidence of Clinically Relevant Cardiac Events	During protocol treatment in randomization period (up to 5 years)	Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths
Incidences of Other Malignancies	Over randomization period of study (median follow-up 35 months)	Other malignancies includes any other malignancy which is not in breast.

Trial Locations

Locations (76): Jefferson Clinic, P.C.
🇺🇸
Birmingham, Alabama, United States
UAB Comprehensive Cancer Center-LNB 301
🇺🇸
Birmingham, Alabama, United States
Providence Alaska Medical Center
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Anchorage, Alaska, United States
University of California, San Diego
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La Jolla, California, United States
University of California at Davis
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Sacramento, California, United States
Los Angeles Biomedical Research Institute
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Torrance, California, United States
University of Connecticut Health Center
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Farmington, Connecticut, United States
Whittingham Cancer Center at Norwalk Hospital
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Norwalk, Connecticut, United States
The George Washington University
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Washington, District of Columbia, United States
Mayo Clinic Jacksonville
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Jacksonville, Florida, United States
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Jefferson Clinic, P.C.
🇺🇸Birmingham, Alabama, United States