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

NCT ID: NCT00083174

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-03
• Study Completion Date: 2018-01-22

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exemestane

one 25 mg tablet daily in am

Group Type: OTHER

exemestane

Intervention Type: DRUG

one 25 mg tablet daily in am

Interventions

exemestane

one 25 mg tablet daily in am

Intervention Type: DRUG

Eligibility Criteria

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 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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Grupo Espanol de Investigacion del Cancer de Mama

OTHER

Sponsor Role: collaborator

UNICANCER

OTHER

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul E. Goss, MD, PhD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

Jefferson Clinic, P.C.

Birmingham, Alabama, United States

UAB Comprehensive Cancer Center-LNB 301

Birmingham, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

University of California, San Diego

La Jolla, California, United States

University of California at Davis

Sacramento, California, United States

Los Angeles Biomedical Research Institute

Torrance, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Whittingham Cancer Center at Norwalk Hospital

Norwalk, Connecticut, United States

The George Washington University

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

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

Georgia Cancer Specialists

Tucker, Georgia, United States

John H. Stroger, Jr Hospital of Cook County

Chicago, Illinois, United States

Mercy Hospital and Medical Center

Chicago, Illinois, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

Loyola University Medical Centre

Maywood, Illinois, United States

Trinity Medical Center

Moline, Illinois, United States

Mid-Illinois Hematology and Oncology Associates, Ltd.

Normal, Illinois, United States

Carle Cancer Centre

Urbana, Illinois, United States

Indiana University Medical Center

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, United States

Suburban Hospital Cancer Program

Bethesda, Maryland, United States

MedStar Health Research Institute

Hyattsville, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Hutzel Women's Health Specialists

Detroit, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Kinston Medical Specialists

Kinston, North Carolina, United States

University of Cincinnati, Barrett Cancer Centre

Cincinnati, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Abramson Cancer Center of the

Philadelphia, Pennsylvania, United States

The Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Univ. of Wisconsin Center for Women's Health and

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, Canada

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Atlantic Health Sciences Corporation

Saint John, New Brunswick, Canada

Northeast Cancer Center Health Sciences

Greater Sudbury, Ontario, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Ottawa Health Research Institute - General Division

Ottawa, Ontario, Canada

Meadowlands Family Health Centre

Ottawa, Ontario, Canada

Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

Toronto East General Hospital

Toronto, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

CHUM - Pavillon Saint-Luc

Montreal, Quebec, Canada

CHA-Hopital Du St-Sacrement

Québec, Quebec, Canada

CRLCC - Paul Papin

Angers, , France

CHU-Hopital A. Morvan

Brest, , France

Centre Francois Baclesse

Caen, , France

CHU de Limoges - Hopital Mere Enfant

Limoges, , France

CHU - Hopital Arnaud de Villeneuve

Montpellier, , France

Centre Rene Gauducheau

Nantes, , France

Clinique Hartmann

Neuilly-sur-Seine, , France

AP-HP Hopital Tenon

Paris, , France

Institut Jean Godinot

Reims, , France

Centre Henri Becquerel

Rouen, , France

Centre Rene Huguenin

Saint-Cloud, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Institut Gustave-Roussy

Villejuif, , France

Orocovis Medical Center

Orocovis, , Puerto Rico

Altamira Family Research Center

San Juan, , Puerto Rico

Countries

United States; Canada; France; Puerto Rico

References

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.

Reference Type: BACKGROUND

PMID: 17593981 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18269782 (View on PubMed)

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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: RESULT

PMID: 21639806 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24711552 (View on PubMed)

Other Identifiers

CAN-NCIC-MAP3

Identifier Type: REGISTRY

Identifier Source: secondary_id

PFIZER-EXEAPO-0028-150

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000363802

Identifier Type: OTHER

Identifier Source: secondary_id

MAP3

Identifier Type: -

Identifier Source: org_study_id

NCT00304486

Identifier Type: -

Identifier Source: nct_alias