Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer (ExCel)
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|ClinicalTrials.gov Identifier: NCT00083174|
Recruitment Status : Completed
First Posted : May 17, 2004
Results First Posted : May 20, 2013
Last Update Posted : April 8, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: exemestane||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4560 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer|
|Actual Study Start Date :||February 11, 2004|
|Actual Primary Completion Date :||March 25, 2011|
|Actual Study Completion Date :||January 22, 2018|
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- Percentage of Women With Serious Adverse Events [ Time Frame: 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) [ Time Frame: 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.
- Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer [ Time Frame: 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 [ Time Frame: Over randomization period of study (median follow-up 35 months) ]
- Number of Clinical Breast Biopsies [ Time Frame: Over randomization period of study (median follow-up 35 months) ]
- Incidence of All Clinical Fractures [ Time Frame: During protocol treatment over randomization period of study (up to 5 years) ]
- Incidence of Clinically Relevant Cardiac Events [ Time Frame: 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 [ Time Frame: Over randomization period of study (median follow-up 35 months) ]Other malignancies includes any other malignancy which is not in breast.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083174
|Study Chair:||Paul E. Goss, MD, PhD||Massachusetts General Hospital|