Skip to content

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

International Breast Cancer Intervention Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00078832
Acronym
IBIS II
Enrollment
3864
Registered
2004-03-09
Start date
2003-09-30
Completion date
2021-05-31
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, chemoprevention

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

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 at least a further 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK ACCRUAL: A total of 3,864 participants were recruited for this study over 10 years.

Interventions

DRUGanastrozole

aromatase inhibitor

DRUGplacebo

Arimidex placebo

Sponsors

Queen Mary University of London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 yearsDec 2013

Secondary

MeasureTime frame
Breast cancer mortality with median follow-up at 10 yearsDec 2018

Countries

Australia, Belgium, Chile, Denmark, Finland, Germany, Hungary, Ireland, Italy, Malta, Portugal, Switzerland, Turkey (Türkiye), United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026