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

Information source: NCIC Clinical Trials Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: exemestane (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: NCIC Clinical Trials Group

Official(s) and/or principal investigator(s):
Paul E. Goss, MD, PhD, Study Chair, Affiliation: Massachusetts General Hospital

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. This study was analyzed in April 2011 and showed a 65% reduction in the incidence of invasive breast cancer in women receiving exemestane compared to women on placebo. 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.

Clinical Details

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

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

Primary outcome:

Frequency of Serious Adverse Events

Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)

Secondary outcome:

Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer

Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events

Number of Clinical Breast Biopsies

Incidence of All Clinical Fractures

Incidence of Clinically Relevant Cardiac Events

Incidences of Other Malignancies

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.

Eligibility

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

CRLCC - Paul Papin, Angers 49933, France

CHU-Hopital A. Morvan, Brest 29608, France

Centre Francois Baclesse, Caen 14076, France

CHU de Limoges - Hopital Mere Enfant, Limoges 87042, France

CHU - Hopital Arnaud de Villeneuve, Montpellier 34295, France

Centre Rene Gauducheau, Nantes 44805, France

Clinique Hartmann, Neuilly Sure Seine 92200, France

AP-HP Hopital Tenon, Paris 75970, France

Institut Jean Godinot, Reims 51056, France

Centre Henri Becquerel, Rouen 76038, France

Centre Rene Huguenin, Saint Cloud 92210, France

Centre Alexis Vautrin, Vandoeuvre les Nancy 54500, France

Institut Gustave-Roussy, Villejuif 94805, France

Orocovis Medical Center, Orocovis 00720, Puerto Rico

Altamira Family Research Center, San Juan 00920, Puerto Rico

Jefferson Clinic, P.C., Birmingham, Alabama 35233, United States

UAB Comprehensive Cancer Center-LNB 301, Birmingham, Alabama 35294-0111, United States

Providence Alaska Medical Center, Anchorage, Alaska 99508, United States

BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia V1Y 5L3, Canada

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia V5Z 4E6, Canada

University of California, San Diego, La Jolla, California 92037, United States

University of California at Davis, Sacramento, California 95817, United States

Los Angeles Biomedical Research Institute, Torrance, California 90502, United States

University of Connecticut Health Center, Farmington, Connecticut 06032, United States

Whittingham Cancer Center at Norwalk Hospital, Norwalk, Connecticut 06856, United States

The George Washington University, Washington, District of Columbia 20037, United States

Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States

University of Miami School of Medicine, Miami, Florida 33136, United States

Georgia Cancer Specialists, Tucker, Georgia 30084, United States

John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois 60612, United States

Mercy Hospital and Medical Center, Chicago, Illinois 60616, United States

The University of Chicago Medical Center, Chicago, Illinois 60637-1470, United States

Loyola University Medical Centre, Maywood, Illinois 60153, United States

Trinity Medical Center, Moline, Illinois 61265, United States

Mid-Illinois Hematology and Oncology Associates, Ltd., Normal, Illinois 61761, United States

Carle Cancer Centre, Urbana, Illinois 61801, United States

Indiana University Medical Center, Indianapolis, Indiana 46202, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7820, United States

Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine 04074-9308, United States

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

Suburban Hospital Cancer Program, Bethesda, Maryland 20817, United States

MedStar Health Research Institute, Hyattsville, Maryland 20782, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Hutzel Women's Health Specialists, Detroit, Michigan 48201, United States

William Beaumont Hospital, Royal Oak, Michigan 48073, United States

Mayo Clinic Rochester, Rochester, Minnesota 55905, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Atlantic Health Sciences Corporation, Saint John, New Brunswick E2L 4L2, Canada

University of Medicine and Dentistry of New Jersey, Newark, New Jersey 07107, United States

Montefiore Medical Center, Bronx, New York 10461, United States

Kinston Medical Specialists, Kinston, North Carolina 28501, United States

University of Cincinnati, Barrett Cancer Centre, Cincinnati, Ohio 45219, United States

University of Oklahoma, Oklahoma City, Oklahoma 73104, United States

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario L8V 5C2, Canada

Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario K7L 5P9, Canada

London Regional Cancer Program, London, Ontario N6A 4L6, Canada

Meadowlands Family Health Centre, Ottawa, Ontario K2C 3R2, Canada

Ottawa Health Research Institute - General Division, Ottawa, Ontario K1H 8L6, Canada

Algoma District Cancer Program, Sault Ste. Marie, Ontario P6B 0A8, Canada

Northeast Cancer Center Health Sciences, Sudbury, Ontario P3E 5J1, Canada

Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada

Odette Cancer Centre, Toronto, Ontario M4N 3M5, Canada

Toronto East General Hospital, Toronto, Ontario M4C 3E7, Canada

Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Women's College Hospital, Toronto, Ontario M5S 1B2, Canada

Abramson Cancer Center of the, Philadelphia, Pennsylvania 19104-4283, United States

CHUM - Hopital Notre-Dame, Montreal, Quebec H2L 4M1, Canada

CHUM - Pavillon Saint-Luc, Montreal, Quebec H3X 3J4, Canada

Hopital Maisonneuve-Rosemont, Montreal, Quebec H1T 2M4, Canada

CHA-Hopital Du St-Sacrement, Quebec City, Quebec G1S 4L8, Canada

The Memorial Hospital of Rhode Island, Pawtucket, Rhode Island 02860, United States

Fletcher Allen Health Care, Burlington, Vermont 05401, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States

Univ. of Wisconsin Center for Women's Health and, Madison, Wisconsin 53715, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Web site for additional information

Related publications:

Richardson H, Johnston D, Pater J, Goss P. The National Cancer Institute of Canada Clinical Trials Group MAP.3 trial: an international breast cancer prevention trial. Curr Oncol. 2007 Jun;14(3):89-96.

Starting date: February 2004
Last updated: April 22, 2015

Page last updated: August 20, 2015

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