NCT00078832 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2021-10-06

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility 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
healthy Volunteers: true
maximum Age: 70 Years
minimum Age: 40 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
anastrozole 1mg
intervention Names
Drug: anastrozole
label
anastrozole
type
EXPERIMENTAL
description
anastrozole 1mg PLACEBO
intervention Names
Drug: placebo
label
placebo
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
anastrozole
description
aromatase inhibitor
name
anastrozole
other Names
Arimidex
type
DRUG
arm Group Labels
placebo
description
Arimidex placebo
name
placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

PREVENTION

Enrollment

count: 3864
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
time Frame
Dec 2013

secondary Outcomes

measure
Breast cancer mortality with median follow-up at 10 years
time Frame
Dec 2018

Full study description

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.

Source references

references

citation
Sestak I, Singh S, Cuzick J, Blake GM, Patel R, Gossiel F, Coleman R, Dowsett M, Forbes JF, Howell A, Eastell R. Changes in bone mineral density at 3 years in postmenopausal women receiving anastrozole and risedronate in the IBIS-II bone substudy: an international, double-blind, randomised, placebo-controlled trial. Lancet Oncol. 2014 Dec;15(13):1460-1468. doi: 10.1016/S1470-2045(14)71035-6. Epub 2014 Nov 11.
pmid
25456365
type
BACKGROUND
citation
Jenkins VA, Ambroisine LM, Atkins L, Cuzick J, Howell A, Fallowfield LJ. Effects of anastrozole on cognitive performance in postmenopausal women: a randomised, double-blind chemoprevention trial (IBIS II). Lancet Oncol. 2008 Oct;9(10):953-61. doi: 10.1016/S1470-2045(08)70207-9. Epub 2008 Sep 1.
pmid
18768369
type
BACKGROUND
citation
Sestak I, Smith SG, Howell A, Forbes JF, Cuzick J. Early participant-reported symptoms as predictors of adherence to anastrozole in the International Breast Cancer Intervention Studies II. Ann Oncol. 2018 Feb 1;29(2):504-509. doi: 10.1093/annonc/mdx713.
pmid
29126161
type
BACKGROUND
citation
Cuzick J, Sestak I, Forbes JF, Dowsett M, Knox J, Cawthorn S, Saunders C, Roche N, Mansel RE, von Minckwitz G, Bonanni B, Palva T, Howell A; IBIS-II investigators. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial. Lancet. 2014 Mar 22;383(9922):1041-8. doi: 10.1016/S0140-6736(13)62292-8. Epub 2013 Dec 12.
pmid
24333009
type
BACKGROUND