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

Phase 3
35 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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



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.

Inclusion 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

- No prior DCIS treated with lumpectomy with or without radiation

- No prior invasive breast cancer

- Not BRCA1 or BRCA2 carriers



- 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

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".



- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Frequency of Serious Adverse Events

Outcome Description:

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

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Paul E. Goss, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Washington University School of Medicine Saint Louis, Missouri  63110
Fletcher Allen Health Care Burlington, Vermont  05401
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Providence Alaska Medical Center Anchorage, Alaska  99508
William Beaumont Hospital Royal Oak, Michigan  48073
University of Connecticut Health Center Farmington, Connecticut  06360-7106
Mayo Clinic Jacksonville Jacksonville, Florida  32224
University of Medicine and Dentistry of New Jersey Newark, New Jersey  07103-2425
Montefiore Medical Center Bronx, New York  10467-2490
Georgia Cancer Specialists Decatur, Georgia  30033
Maine Center for Cancer Medicine and Blood Disorders Scarborough, Maine  04074
Mercy Hospital and Medical Center Chicago, Illinois  60616
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Trinity Medical Center Moline, Illinois  61265-1291
University of Oklahoma Oklahoma City, Oklahoma  73190
Kinston Medical Specialists Kinston, North Carolina  28501
Whittingham Cancer Center at Norwalk Hospital Norwalk, Connecticut  06856
The University of Chicago Medical Center Chicago, Illinois  60637-1470
Suburban Hospital Cancer Program Bethesda, Maryland  20817
Indiana University Medical Center Indianapolis, Indiana  46202
University of California, San Diego La Jolla, California  92037-1709
University of Miami School of Medicine Miami, Florida  33136
University of Cincinnati, Barrett Cancer Centre Cincinnati, Ohio  45219
Mayo Clinic Rochester Rochester, Minnesota  55905
Jefferson Clinic, P.C. Birmingham, Alabama  35233
UAB Comprehensive Cancer Center-LNB 301 Birmingham, Alabama  35294-0111
University of California at Davis Sacramento, California  95817
Los Angeles Biomedical Research Institute Torrance, California  90502
The George Washington University Washington, District of Columbia  20037
John H. Stroger, Jr Hospital of Cook County Chicago, Illinois  60612
Loyola University Medical Centre Maywood, Illinois  60153
Mid-Illinois Hematology and Oncology Associates, Ltd. Normal, Illinois  61761
Carle Cancer Centre Urbana, Illinois  61801
MedStar Health Research Institute Hyattsville, Maryland  20782
Hutzel Women's Health Specialists Detroit, Michigan  48201
Abramson Cancer Center of the Philadelphia, Pennsylvania  19104-4283
The Memorial Hospital of Rhode Island Pawtucket, Rhode Island  02860
Univ. of Wisconsin Center for Women's Health and Madison, Wisconsin  53715