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Breast CancerPhase 3ExCelNCT00083174

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

A Phase 3 study testing exemestane in people with Breast Cancer, run by NCIC Clinical Trials Group at 76 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,560 participants
Where
76 sitesin 4 countries
Study dates
3 Dec 2004to 22 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult
  • 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.

Trial locations and contacts

76 sites in 4 countries.

76 sites in 4 countries

United States41 sites

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Suburban Hospital Cancer Program

    Bethesda, Maryland, 20817

  • Jefferson Clinic, P.C.

    Birmingham, Alabama, 35233

  • UAB Comprehensive Cancer Center-LNB 301

    Birmingham, Alabama, 35294-0111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • John H. Stroger, Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637-1470

  • University of Cincinnati, Barrett Cancer Centre

    Cincinnati, Ohio, 45219

  • Hutzel Women's Health Specialists

    Detroit, Michigan, 48201

  • University of Connecticut Health Center

    Farmington, Connecticut, 06032

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7820

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • University of California, San Diego

    La Jolla, California, 92037

  • Univ. of Wisconsin Center for Women's Health and

    Madison, Wisconsin, 53715

  • Loyola University Medical Centre

    Maywood, Illinois, 60153

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Trinity Medical Center

    Moline, Illinois, 61265

  • University of Medicine and Dentistry of New Jersey

    Newark, New Jersey, 07107

  • Mid-Illinois Hematology and Oncology Associates, Ltd.

    Normal, Illinois, 61761

  • Whittingham Cancer Center at Norwalk Hospital

    Norwalk, Connecticut, 06856

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • The Memorial Hospital of Rhode Island

    Pawtucket, Rhode Island, 02860

  • Abramson Cancer Center of the

    Philadelphia, Pennsylvania, 19104-4283

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • University of California at Davis

    Sacramento, California, 95817

  • Maine Center for Cancer Medicine and Blood Disorders

    Scarborough, Maine, 04074-9308

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Los Angeles Biomedical Research Institute

    Torrance, California, 90502

  • Georgia Cancer Specialists

    Tucker, Georgia, 30084

  • Carle Cancer Centre

    Urbana, Illinois, 61801

  • The George Washington University

    Washington D.C., District of Columbia, 20037

Other trials in United States

Canada20 sites

  • Northeast Cancer Center Health Sciences

    Greater Sudbury, Ontario, P3E 5J1

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • CHUM - Pavillon Saint-Luc

    Montreal, Quebec, H3X 3J4

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario, K1H 8L6

  • Meadowlands Family Health Centre

    Ottawa, Ontario, K2C 3R2

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2

  • Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

France13 sites

  • CRLCC - Paul Papin

    Angers, 49933

  • CHU-Hopital A. Morvan

    Brest, 29608

  • Centre Francois Baclesse

    Caen, 14076

  • CHU de Limoges - Hopital Mere Enfant

    Limoges, 87042

  • CHU - Hopital Arnaud de Villeneuve

    Montpellier, 34295

  • Centre Rene Gauducheau

    Nantes, 44805

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • AP-HP Hopital Tenon

    Paris, 75970

  • Institut Jean Godinot

    Reims, 51056

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54500

  • Institut Gustave-Roussy

    Villejuif, 94805

Other trials in France

Puerto Rico2 sites

  • Orocovis Medical Center

    Orocovis, 00720

  • Altamira Family Research Center

    San Juan, 00920

Other trials in Puerto Rico

About this study

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

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.

Read the 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
Being tested
exemestane
Keywords
breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exemestaneDrug

    one 25 mg tablet daily in am

Study groups in NCT00083174
Study groupRoleWhat they receive
ExemestaneOtherone 25 mg tablet daily in am
Receives: Drug: exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years open-label extension period

  2. 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.

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

Secondary outcomes (6)

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

    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.

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

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

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

  3. Number of Clinical Breast Biopsies

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

  4. Incidence of All Clinical Fractures

    Measured: During protocol treatment over randomization period of study (up to 5 years)

  5. Incidence of Clinically Relevant Cardiac Events

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

    Measured: During protocol treatment in randomization period (up to 5 years)

  6. Incidences of Other Malignancies

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2004 (estimated)
  2. Study start3 Dec 2004
  3. Primary completion25 Mar 2011
  4. Study completion22 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4,560 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083174
Sponsor's protocol ID
MAP3
Other IDs
CAN-NCIC-MAP3, PFIZER-EXEAPO-0028-150, CDR0000363802
Acronym
ExCel
Status last verified
Mar 2020
First submitted
14 May 2004
Last updated
25 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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. doi: 10.3747/co.2007.117.

    PubMed 17593981

  • 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.

    PubMed 18269782

  • 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.

  • 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.

  • 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.

  • 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.

    PubMed 21639806

  • 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.

    PubMed 24711552

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exemestane in people with Breast Cancer, run by NCIC Clinical Trials Group at 76 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Canada, France, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Women With Serious Adverse Events (time frame: 5 years open-label extension period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083174, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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