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Status:

COMPLETED

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

Lead Sponsor:

NCIC Clinical Trials Group

Collaborating Sponsors:

Grupo Espanol de Investigacion del Cancer de Mama

UNICANCER

Conditions:

Breast Cancer

Eligibility:

FEMALE

35+ years

Phase:

PHASE3

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 M...

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    December 3 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 22 2018

    Estimated Enrollment :

    4560 Patients enrolled

    Trial Details

    Trial ID

    NCT00083174

    Start Date

    December 3 2004

    End Date

    January 22 2018

    Last Update

    August 25 2023

    Active Locations (76)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 19 (76 locations)

    1

    Jefferson Clinic, P.C.

    Birmingham, Alabama, United States, 35233

    2

    UAB Comprehensive Cancer Center-LNB 301

    Birmingham, Alabama, United States, 35294-0111

    3

    Providence Alaska Medical Center

    Anchorage, Alaska, United States, 99508

    4

    University of California, San Diego

    La Jolla, California, United States, 92037