Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-30 @ 10:24 PM
Study NCT ID:
NCT00078832
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2004-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand', 'Peru', 'Russia'], 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-24', 'releaseDate': '2022-10-07'}, {'resetDate': '2024-03-21', 'releaseDate': '2023-09-20'}], 'estimatedResultsFirstSubmitDate': '2022-10-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3864}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2004-03-08', 'studyFirstSubmitQcDate': '2004-03-08', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years', 'timeFrame': 'Dec 2013'}], 'secondaryOutcomes': [{'measure': 'Breast cancer mortality with median follow-up at 10 years', 'timeFrame': 'Dec 2018'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer, chemoprevention'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '25456365', 'type': 'BACKGROUND', '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': '18768369', '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': '29126161', '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': '24333009', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-anastrozole-to-prevent-breast-cancer-in-postmenopausal-women', 'label': 'Clinical trial summary from Cancer Research UK Website'}, {'url': 'https://www.ibis-trials.org/thetrials/ibistrials/ibis-2-prevention', 'label': 'IBIS-II website'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease.\n\nSecondary\n\n* Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants.\n* Determine the effect of this drug on breast cancer mortality in these participants.\n* Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants.\n* Determine the tolerability and acceptability of side effects of this drug in these participants.\n\nOUTLINE: 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.\n\n* Arm I: Participants receive oral anastrozole daily for 5 years.\n* 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.\n\nParticipants are followed for at least a further 5 years.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nACCRUAL: A total of 3,864 participants were recruited for this study over 10 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets at least 1 of the relative risk factors based on age as follows:\n\n * 45 to 70 years of age:\n\n * First-degree relative who developed breast cancer at ≤ 50 years of age\n * First-degree relative who developed bilateral breast cancer\n * Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer\n\n * 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\n * Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer\n * Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer\n * Mammographic opacity covering at least 50% of the breast in the absence of hormone replacement therapy within the past 3 months\n * 60 to 70 years of age:\n\n * First-degree relative with breast cancer at any age\n * Age at menopause ≥ 55 years\n * Nulliparous or age at first birth ≥ 30 years\n * 40 to 44 years of age:\n\n * Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer at ≤ 50 years of age\n * First-degree relative with bilateral breast cancer who developed the first breast cancer at ≤ 50 years of age\n * Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer at ≤ 40 years of age\n * Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer at ≤ 40 years of age\n* 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\n\n * Clearly apparent family history AND/OR other risk factors indicating appropriate increased risk of breast cancer for age\n* The following prior breast conditions are allowed (for all age groups):\n\n * Lobular carcinoma in situ\n * Atypical ductal or lobular hyperplasia in a benign lesion\n * Ductal carcinoma in-situ (DCIS), diagnosed within the past 6 months, and treated by mastectomy\n* No evidence of breast cancer on mammogram within the past year\n* Hormone receptor status:\n\n * For patients with prior DCIS, estrogen- or progesterone-receptor status must have been positive\n\n * Must have had greater than or equal to 5% positive cells\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 40 to 70\n\nSex\n\n* Female\n\nMenopausal status\n\n* Postmenopausal, defined as at least 1 of the following:\n\n * Over 60 years of age\n * Bilateral oophorectomy\n * ≤ 60 years of age with a uterus and amenorrhea for at least 12 months\n * ≤ 60 years of age without a uterus and with follicle-stimulating hormone levels \\> 30 IU/L\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* At least 10 years\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* Psychologically and physically suitable to receive 5 years of anti-estrogen therapy\n* No cancer within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix\n* No evidence of osteoporosis or fragility fractures within the spine\n\n * Participants with a T-score \\> minus 4 and no more than 2 fragility fractures are allowed\n* No concurrent severe disease that would place the participant at unusual risk or confound the results of the study\n* No other medical condition that would preclude the ability to receive the study treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* 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.\n* No concurrent tamoxifen, raloxifene, or other SERM\n* No concurrent estrogen-based hormone replacement therapy\n* No concurrent systemic estrogen replacement therapy, including vaginal estrogen preparations\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n* No prior prophylactic mastectomy\n* No concurrent prophylactic mastectomy\n\nOther\n\n* More than 6 months since prior investigational drugs'}, 'identificationModule': {'nctId': 'NCT00078832', 'acronym': 'IBIS II', 'briefTitle': 'Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'International Breast Cancer Intervention Study', 'orgStudyIdInfo': {'id': 'ISRCTN31488319'}, 'secondaryIdInfos': [{'id': 'EU-20227'}, {'id': 'EUDRACT-2004-003991-12'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anastrozole', 'description': 'anastrozole 1mg', 'interventionNames': ['Drug: anastrozole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'anastrozole 1mg PLACEBO', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'anastrozole', 'type': 'DRUG', 'otherNames': ['Arimidex'], 'description': 'aromatase inhibitor', 'armGroupLabels': ['anastrozole']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Arimidex placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2310', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Newcastle Mater Hospital', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Corporacion Nacional del Cancer', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': 'Dk- 2730 Herlev', 'city': 'Hørsholm', 'country': 'Denmark', 'facility': 'Herlev University Hospital', 'geoPoint': {'lat': 55.88098, 'lon': 12.50111}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Pirkanmaa Cancer Society', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '63263', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'GBG Forschungs GMBH', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Department of Oncotherapy, University of Szeged', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, 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'facility': 'Department of General Surgery Pennine Acute Hospitals NHS Trust', 'geoPoint': {'lat': 53.54051, 'lon': -2.1183}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Cancer Clinical Trials Centre', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Weston Park Hospital, Cancer Clinical Trials Centre, Department of Clinical Oncology', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 5YA', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Princess Anne Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'ST16 3SA', 'city': 'Stafford', 'country': 'United Kingdom', 'facility': 'Mid Staffordshire NHS Foundation Trust', 'geoPoint': {'lat': 52.80521, 'lon': -2.11636}}, {'zip': 'TR1 3LJ', 'city': 'Truro', 'country': 'United Kingdom', 'facility': 'Treliske Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'ML2 0DP', 'city': 'Wishaw', 'country': 'United Kingdom', 'facility': 'Wishaw General Hospital', 'geoPoint': {'lat': 55.76667, 'lon': -3.91667}}, {'zip': 'BA21 4AT', 'city': 'Yeovil', 'country': 'United Kingdom', 'facility': 'Yeovil District Hospital', 'geoPoint': {'lat': 50.94159, 'lon': -2.63211}}], 'overallOfficials': [{'name': 'Jack Cuzick, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Queen Mary University of London'}, {'name': 'Anthony Howell', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-10-07', 'type': 'RELEASE'}, {'date': '2023-08-24', 'type': 'RESET'}, {'date': '2023-09-20', 'type': 'RELEASE'}, {'date': '2024-03-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Queen Mary University of London'}}}}