Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer (IBIS II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jill Knox, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT00078832
First received: March 8, 2004
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: International Breast Cancer Intervention Study

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years [ Time Frame: Dec 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breast cancer mortality with median follow-up at 10 years [ Time Frame: Dec 2018 ] [ Designated as safety issue: No ]

Enrollment: 3864
Study Start Date: September 2003
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: anastrozole
    aromatase inhibitor
    Other Name: Arimidex
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 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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078832

  Show 75 Study Locations
Sponsors and Collaborators
Jill Knox
Investigators
Study Chair: Jack Cuzick, PhD Queen Mary's University
  More Information

Additional Information:
No publications provided

Responsible Party: Jill Knox, Project Manager, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT00078832     History of Changes
Other Study ID Numbers: ISRCTN31488319, EU-20227, EUDRACT-2004-003991-12
Study First Received: March 8, 2004
Last Updated: April 13, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Mary University of London:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014