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

NCT00083174 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: MAP3CAN-NCIC-MAP3PFIZER-EXEAPO-0028-150CDR0000363802
• Study Type: interventional
• Target: 4,560
• Locations: 4 countries
• Sites: 76

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Women With Serious Adverse Events

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

  5 years open-label extension period

• Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)

  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.

  Over randomization period of study (median follow-up 35 months)

Secondary Outcomes (6)

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

  Over randomization period of study (median follow-up 35 months)

• 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)

Study Arms (1)

Exemestane

OTHER

one 25 mg tablet daily in am

Drug: exemestane

Interventions

exemestane DRUG

one 25 mg tablet daily in am

Exemestane

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• Grupo Espanol de Investigacion del Cancer de Mama: collaborator
• UNICANCER: collaborator

Study Sites (76)

Jefferson Clinic, P.C.

Birmingham, Alabama, 35233, United States

Location

UAB Comprehensive Cancer Center-LNB 301

Birmingham, Alabama, 35294-0111, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of California at Davis

Sacramento, California, 95817, United States

Location

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06032, United States

Location

Whittingham Cancer Center at Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

The George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Georgia Cancer Specialists

Tucker, Georgia, 30084, United States

Location

John H. Stroger, Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637-1470, United States

Location

Loyola University Medical Centre

Maywood, Illinois, 60153, United States

Location

Trinity Medical Center

Moline, Illinois, 61265, United States

Location

Mid-Illinois Hematology and Oncology Associates, Ltd.

Normal, Illinois, 61761, United States

Location

Carle Cancer Centre

Urbana, Illinois, 61801, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7820, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074-9308, United States

Location

Suburban Hospital Cancer Program

Bethesda, Maryland, 20817, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Hutzel Women's Health Specialists

Detroit, Michigan, 48201, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07107, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

University of Cincinnati, Barrett Cancer Centre

Cincinnati, Ohio, 45219, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Abramson Cancer Center of the

Philadelphia, Pennsylvania, 19104-4283, United States

Location

The Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Univ. of Wisconsin Center for Women's Health and

Madison, Wisconsin, 53715, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

Northeast Cancer Center Health Sciences

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Meadowlands Family Health Centre

Ottawa, Ontario, K2C 3R2, Canada

Location

Algoma District Cancer Program

Sault Ste. Marie, Ontario, P6B 0A8, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

CHUM - Pavillon Saint-Luc

Montreal, Quebec, H3X 3J4, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

CRLCC - Paul Papin

Angers, 49933, France

Location

CHU-Hopital A. Morvan

Brest, 29608, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

CHU de Limoges - Hopital Mere Enfant

Limoges, 87042, France

Location

CHU - Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Centre Rene Gauducheau

Nantes, 44805, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

AP-HP Hopital Tenon

Paris, 75970, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54500, France

Location

Institut Gustave-Roussy

Villejuif, 94805, France

Location

Orocovis Medical Center

Orocovis, 00720, Puerto Rico

Location

Altamira Family Research Center

San Juan, 00920, Puerto Rico

Location

Related Publications (7)

• 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. doi: 10.3747/co.2007.117.

  PMID: 17593981 BACKGROUND

• Goss PE, Richardson H, Chlebowski R, Johnston D, Sarto GE, Maunsell E, Ingle JN, Ales-Martinez JE. National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: evaluation of exemestane to prevent breast cancer in postmenopausal women. Clin Breast Cancer. 2007 Dec;7(11):895-900. doi: 10.3816/CBC.2007.n.057. No abstract available.

  PMID: 18269782 RESULT

• Moy B, Richardson H, Johnston D, et al.: NCIC CTG MAP.3: enrollment and study drug adherence of ethnic minority women in a breast cancer prevention trial. [Abstract] Breast Cancer Res Treat 106 (1): A-3048, S141-2, 2007.

  RESULT

• Richardson H, Johnston D, Goss PE, et al.: Participant characteristics on an international NCIC CTG breast cancer prevention trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-1531, 2007.

  RESULT

• Goss PE, Ingle JN, Alés-Martinez J, Cheung A, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson K, Martin L, Winquist E, Sarto G, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H. Exemestane for primary prevention of breast cancer in postmenopausal women: NCIC CTG MAP.3 - A randomized placebo-controlled clinical trial. J Clin Oncol 29[suppl; abstr LBA504], 2011.

  RESULT

• Goss PE, Ingle JN, Ales-Martinez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson KC, Martin LW, Winquist E, Sarto GE, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H; NCIC CTG MAP.3 Study Investigators. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med. 2011 Jun 23;364(25):2381-91. doi: 10.1056/NEJMoa1103507. Epub 2011 Jun 4.

  PMID: 21639806 RESULT

• Maunsell E, Goss PE, Chlebowski RT, Ingle JN, Ales-Martinez JE, Sarto GE, Fabian CJ, Pujol P, Ruiz A, Cooke AL, Hendrix S, Thayer DW, Rowland KM, Dube P, Spadafora S, Pruthi S, Lickley L, Ellard SL, Cheung AM, Wactawski-Wende J, Gelmon KA, Johnston D, Hiltz A, Brundage M, Pater JL, Tu D, Richardson H. Quality of life in MAP.3 (Mammary Prevention 3): a randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. J Clin Oncol. 2014 May 10;32(14):1427-36. doi: 10.1200/JCO.2013.51.2483. Epub 2014 Apr 7.

  PMID: 24711552 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Biostatistician
• Organization: Canadian Cancer Trials Group

dtu@ctg.queensu.ca

613-533-6430

Study Officials

• Paul E. Goss, MD, PhD

  Massachusetts General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 17, 2004
• Study Start: December 3, 2004
• Primary Completion: March 25, 2011
• Study Completion: January 22, 2018
• Last Updated: August 25, 2023
• Results First Posted: May 20, 2013

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (20); FR (13); PR (2); US (41)