Completed
ExCel

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

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What is being tested

exemestane

Drug
Who is being recruted

Breast Cancer

Over 35 Years

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: December 2004

See protocol details

Summary

Principal SponsorNCIC Clinical Trials Group
Last updated: August 25, 2023
Sourced from a government-validated database.Claim as a partner
Study start date: December 3, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer 
Principal SponsorNCIC Clinical Trials Group
Last updated: August 25, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
4560 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 35 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
Criteria

* At increased risk of developing breast cancer, due to at least one of the following risk factors: * Gail score ≥ 1.66 * Age ≥ 60 years * Prior atypical ductal hyperplasia, lobular hyperplasia, or lobular carcinoma in situ on breast biopsy * Prior ductal carcinoma in situ (DCIS) treated with total mastectomy with or without tamoxifen (tamoxifen must have been completed ≥ 3 months prior to randomization) * No prior DCIS treated with lumpectomy with or without radiation * No prior invasive breast cancer * Not BRCA1 or BRCA2 carriers PATIENT CHARACTERISTICS: Previous: * 35 and over * Female * Postmenopausal, defined as one of the following: * over 50 years of age with no spontaneous menses for at least 12 months before study entry * 50 years of age or under with no menses (spontaneous or secondary to hysterectomy) for at least 12 months before study entry AND with follicle-stimulating hormone level within postmenopausal range * Underwent prior bilateral oophorectomy * No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years * No uncontrolled hypothyroidism or hyperthyroidism * No major medical or psychiatric illness (including substance and alcohol abuse within the past 2 years) that would preclude study participation or compliance * Must be accessible for treatment and follow-up * Willing to complete quality of life questionnaires in either English or French Current: MAP.3 participants who were randomized to the exemestane arm, are currently receiving exemestane as part of the MAP.3 study and who have not completed 5 years of exemestane. OR MAP.3 study participants who were randomized to the placebo arm and who have either completed 5 years of study drug or who are still receiving placebo. Note: this applies only to centres that choose to allow placebo "cross-over". PRIOR CONCURRENT THERAPY: Previous: * More than 3 months since prior and no concurrent hormone replacement therapies * More than 3 months since systemic estrogenic, androgenic, or progestational agents * More than 3 months since prior and no concurrent hormonal therapies, including, but not limited to the following: * Luteinizing-hormone releasing-hormone analogs (e.g., goserelin or leuprolide) * Progestogens (e.g., megestrol) * Prolactin inhibitors (e.g., bromocriptine) * Antiandrogens (e.g., cyproterone acetate) * Selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene) * No investigational drug within 30 days or 5 half lives prior to randomization * No concurrent endocrine therapy * No concurrent estrogens, androgens, or progesterones * Concurrent low dose (≤ 100 mg/day) prophylactic aspirin allowed * Concurrent bisphosphonates for prevention or treatment of osteoporosis allowed * No other concurrent medications that may have an effect on study endpoints Current: There are no prior concurrent therapy restrictions for the amended MAP.3 study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
one 25 mg tablet daily in am
Study Objectives
Primary Objectives

Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.

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 Objectives

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.

Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths

Other malignancies includes any other malignancy which is not in breast.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 76 locations
Suspended
Jefferson Clinic, P.C.Birmingham, United StatesSee the location
Suspended
UAB Comprehensive Cancer Center-LNB 301Birmingham, United States
Suspended
Providence Alaska Medical CenterAnchorage, United States
Suspended
University of California, San DiegoLa Jolla, United States
Completed76 Study Centers