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Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
This study is currently recruiting participants.
Study NCT00078832   Information provided by National Cancer Institute (NCI)
First Received: March 8, 2004   Last Updated: October 6, 2009   History of Changes

March 8, 2004
October 6, 2009
September 2003
 
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years [ Designated as safety issue: No ]
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
Complete list of historical versions of study NCT00078832 on ClinicalTrials.gov Archive Site
Breast cancer mortality with median follow-up at 10 years [ Designated as safety issue: No ]
Breast cancer mortality with median follow-up at 10 years
 
Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
An International Multi-Centre Study Of Anastrozole Versus Placebo In Postmenopausal Women At Increased Risk Of Breast Cancer

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 trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.

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 in preventing estrogen receptor-positive breast cancer in these participants.
  • Determine the effect of this drug on breast cancer mortality in these participants.
  • Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants.
  • Determine the tolerability and acceptability of side effects of this drug in these participants.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to participating center. Participants are randomized to 1 of 2 treatment arms.

  • Arm I: Participants receive oral anastrozole daily for 5 years.
  • Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment continues in the absence of the development of breast cancer (including ductal carcinoma in situ), a drop in the T-score below minus 4, or the occurrence of a new fragility fracture.

Participants are followed for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 6,000 participants will be accrued for this study.

 
Interventional
Prevention, Randomized, Double-Blind, Placebo Control
Breast Cancer
Drug: anastrozole
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
6000
 
 

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 > 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 nonmelanoma 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 3 months in duration
  • 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 3 months since prior investigational drugs
  • No prior participation in IBIS-I
  • No concurrent participation in IBIS-I
Female
40 Years to 70 Years
No
 
Australia,   Belgium,   Chile,   Denmark,   Finland,   Ireland,   Italy,   New Zealand,   Peru,   Portugal,   Switzerland,   United Kingdom
 
NCT00078832
 
CDR0000353186, CRUK-IBIS-IIB, EU-20227, IBCSG-31-03-PREV, EUDRACT-2004-003991-12
Queen Mary University of London
International Breast Cancer Study Group
Investigator: Jack Cuzick, PhD Cancer Research UK
Principal Investigator: Katharina S. Buser, MD Oncocare Sonnenhof-Klinik Engeriedspital
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP