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Status:

COMPLETED

Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer

Lead Sponsor:

Queen Mary University of London

Conditions:

Breast Cancer

Eligibility:

FEMALE

40-70 years

Phase:

PHASE3

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Anastrozole may be effective in preventing breast cancer. PURPOSE: This randomized clinical...

Detailed Description

OBJECTIVES: Primary * Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease. Secondary * Determine the role of this drug ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Meets at least 1 of the relative risk factors based on age as follows:
  • 45 to 70 years of age:
  • First-degree relative who developed breast cancer at ≤ 50 years of age
  • First-degree relative who developed bilateral breast cancer
  • Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer
  • Participants having both relatives who are second degree and on the opposite sides of the family must have at least one that was diagnosed at ≤ 50 years of age
  • Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer
  • Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer
  • Mammographic opacity covering at least 50% of the breast in the absence of hormone replacement therapy within the past 3 months
  • 60 to 70 years of age:
  • First-degree relative with breast cancer at any age
  • Age at menopause ≥ 55 years
  • Nulliparous or age at first birth ≥ 30 years
  • 40 to 44 years of age:
  • Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer at ≤ 50 years of age
  • First-degree relative with bilateral breast cancer who developed the first breast cancer at ≤ 50 years of age
  • Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer at ≤ 40 years of age
  • Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer at ≤ 40 years of age
  • All age groups (40 to 70 ears of age) with a 10-year risk \> 5% who do not fit into the above categories are allowed
  • Clearly apparent family history AND/OR other risk factors indicating appropriate increased risk of breast cancer for age
  • The following prior breast conditions are allowed (for all age groups):
  • Lobular carcinoma in situ
  • Atypical ductal or lobular hyperplasia in a benign lesion
  • Ductal carcinoma in-situ (DCIS), diagnosed within the past 6 months, and treated by mastectomy
  • No evidence of breast cancer on mammogram within the past year
  • Hormone receptor status:
  • For patients with prior DCIS, estrogen- or progesterone-receptor status must have been positive
  • Must have had greater than or equal to 5% positive cells
  • PATIENT CHARACTERISTICS:
  • Age
  • 40 to 70
  • Sex
  • Female
  • Menopausal status
  • Postmenopausal, defined as at least 1 of the following:
  • Over 60 years of age
  • Bilateral oophorectomy
  • ≤ 60 years of age with a uterus and amenorrhea for at least 12 months
  • ≤ 60 years of age without a uterus and with follicle-stimulating hormone levels \> 30 IU/L
  • Performance status
  • Not specified
  • Life expectancy
  • At least 10 years
  • Hematopoietic
  • Not specified
  • Hepatic
  • Not specified
  • Renal
  • Not specified
  • Other
  • Psychologically and physically suitable to receive 5 years of anti-estrogen therapy
  • No cancer within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix
  • No evidence of osteoporosis or fragility fractures within the spine
  • Participants with a T-score \> minus 4 and no more than 2 fragility fractures are allowed
  • No concurrent severe disease that would place the participant at unusual risk or confound the results of the study
  • No other medical condition that would preclude the ability to receive the study treatment
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • No prior tamoxifen, raloxifene, or other selective estrogen receptor modulator (SERM) use for more than 6 months in duration unless an IBIS-I participant (must have been off trial therapy for at least 5 years.
  • No concurrent tamoxifen, raloxifene, or other SERM
  • No concurrent estrogen-based hormone replacement therapy
  • No concurrent systemic estrogen replacement therapy, including vaginal estrogen preparations
  • Radiotherapy
  • Not specified
  • Surgery
  • See Disease Characteristics
  • No prior prophylactic mastectomy
  • No concurrent prophylactic mastectomy
  • Other
  • More than 6 months since prior investigational drugs

Exclusion

    Key Trial Info

    Start Date :

    September 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 31 2021

    Estimated Enrollment :

    3864 Patients enrolled

    Trial Details

    Trial ID

    NCT00078832

    Start Date

    September 1 2003

    End Date

    May 31 2021

    Last Update

    October 6 2021

    Active Locations (74)

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

    Page 1 of 19 (74 locations)

    1

    Newcastle Mater Hospital

    Newcastle, New South Wales, Australia, 2310

    2

    University Hospitals

    Leuven, Belgium, B-3000

    3

    Corporacion Nacional del Cancer

    Santiago, Chile

    4

    Herlev University Hospital

    Hørsholm, Denmark, Dk- 2730 Herlev