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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
N/A
Open (Enrolling)
Female
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


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.

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.

Type of Study:

Interventional

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:

Yes

Principal Investigator

Paul E. Goss, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

MAP3

NCT ID:

NCT00083174

Start Date:

February 2004

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Washington University School of MedicineSaint Louis, Missouri  63110
Fletcher Allen Health CareBurlington, Vermont  05401
Medical College of WisconsinMilwaukee, Wisconsin  53226
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Providence Alaska Medical CenterAnchorage, Alaska  99508
William Beaumont HospitalRoyal Oak, Michigan  48073
University of Connecticut Health CenterFarmington, Connecticut  06360-7106
Mayo Clinic JacksonvilleJacksonville, Florida  32224
University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425
Montefiore Medical CenterBronx, New York  10467-2490
Georgia Cancer SpecialistsDecatur, Georgia  30033
Maine Center for Cancer Medicine and Blood DisordersScarborough, Maine  04074
Mercy Hospital and Medical CenterChicago, Illinois  60616
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Trinity Medical CenterMoline, Illinois  61265-1291
University of OklahomaOklahoma City, Oklahoma  73190
Kinston Medical SpecialistsKinston, North Carolina  28501
Whittingham Cancer Center at Norwalk HospitalNorwalk, Connecticut  06856
The University of Chicago Medical CenterChicago, Illinois  60637-1470
Suburban Hospital Cancer ProgramBethesda, Maryland  20817
Indiana University Medical CenterIndianapolis, Indiana  46202
University of California, San DiegoLa Jolla, California  92037-1709
University of Miami School of MedicineMiami, Florida  33136
University of Cincinnati, Barrett Cancer CentreCincinnati, Ohio  45219
Mayo Clinic RochesterRochester, Minnesota  55905
Jefferson Clinic, P.C.Birmingham, Alabama  35233
UAB Comprehensive Cancer Center-LNB 301Birmingham, Alabama  35294-0111
University of California at DavisSacramento, California  95817
Los Angeles Biomedical Research InstituteTorrance, California  90502
The George Washington UniversityWashington, District of Columbia  20037
John H. Stroger, Jr Hospital of Cook CountyChicago, Illinois  60612
Loyola University Medical CentreMaywood, Illinois  60153
Mid-Illinois Hematology and Oncology Associates, Ltd.Normal, Illinois  61761
Carle Cancer CentreUrbana, Illinois  61801
MedStar Health Research InstituteHyattsville, Maryland  20782
Hutzel Women's Health SpecialistsDetroit, Michigan  48201
Abramson Cancer Center of thePhiladelphia, Pennsylvania  19104-4283
The Memorial Hospital of Rhode IslandPawtucket, Rhode Island  02860
Univ. of Wisconsin Center for Women's Health andMadison, Wisconsin  53715