Breast Cancer Clinical Trial
— IBIS IIOfficial title:
International Breast Cancer Intervention Study
Verified date | April 2018 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3864 |
Est. completion date | May 31, 2021 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Newcastle Mater Hospital | Newcastle | New South Wales |
Belgium | University Hospitals | Leuven | |
Chile | Corporacion Nacional del Cancer | Santiago | |
Denmark | Herlev University Hospital | Horsholm | |
Finland | Pirkanmaa Cancer Society | Tampere | |
Germany | GBG Forschungs GMBH | Frankfurt | |
Hungary | Department of Oncotherapy, University of Szeged | Szeged | |
Ireland | Cork University Hospital | Cork | |
Ireland | South Infirmary Victoria Hospital | Cork | |
Ireland | Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital | Dublin | Tallaght |
Ireland | Beaumont Hospital | Dublin | Beaumont |
Ireland | St. James's Hospital | Dublin | |
Ireland | St. Vincent's University Hospital | Dublin | |
Ireland | University College Hospital | Galway | |
Ireland | Mid-Western Cancer Centre at Mid-Western Regional Hospital | Limerick | |
Ireland | Sligo General Hospital | Sligo | |
Italy | Division of Chemoprevention | Milan | |
Malta | Sir Paul Boffa Hospital, Harper Lane | Floriana | |
Portugal | Instituto Portugues De Oncologia, Gabinete De Estudos Clinicos | Lisbon | |
Switzerland | Inselspital Bern | Bern | |
Switzerland | Oncocare Sonnenhof-Klinik Engeriedspital | Bern | |
Switzerland | Hopital Cantonal Universitaire de Geneve | Geneva | |
Switzerland | Ospedale Beata Vergine | Mendrisio | |
Switzerland | Tumor Zentrum ZeTup St. Gallen und Chur | St. Gallen | |
Switzerland | Regionalspital | Thun | |
Turkey | Ortaklar cad Pehlivan sok, Basak koviah ap. | Istanbul | |
United Kingdom | Aberdeen Royal Infirmary | Aberdeen | |
United Kingdom | Tameside General Hospital | Ashton-Under-Lyne | England |
United Kingdom | Centre for Cancer Research and Cell Biology at Queen's University Belfast | Belfast | Northern Ireland |
United Kingdom | Royal Bolton Hospital | Bolton | England |
United Kingdom | Royal Bournemouth Hospital | Bournemouth | England |
United Kingdom | St. Luke's Hospital | Bradford | England |
United Kingdom | Sussex Cancer Centre at Royal Sussex County Hospital | Brighton | England |
United Kingdom | Bristol Royal Infirmary | Bristol | England |
United Kingdom | Frenchay Hospital | Bristol | England |
United Kingdom | Queen's Hospital | Burton-upon-Trent | England |
United Kingdom | University Hospital of Wales | Cardiff | Wales |
United Kingdom | Broomfield Hospital | Chelmsford | England |
United Kingdom | Gloucestershire Oncology Centre at Cheltenham General Hospital | Cheltenham | England |
United Kingdom | Countess of Chester Hospital | Chester | England |
United Kingdom | Essex County Hospital | Colchester | England |
United Kingdom | Royal Derby Hospital | Derby | England |
United Kingdom | Ninewells Hospital | Dundee | Scotland |
United Kingdom | Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland |
United Kingdom | Saint Margaret's Hospital, | Epping | England |
United Kingdom | Royal Devon and Exeter Hospital | Exeter | England |
United Kingdom | Frimley Park Hospital | Frimley | England |
United Kingdom | Lincoln County Hospital | Grantham | |
United Kingdom | Conquest Hospital | Hastings | England |
United Kingdom | Calderdale Royal Hospital | Huddersfield | |
United Kingdom | Castle Hill Hospital | Hull | England |
United Kingdom | Airedale General Hospital | Keighley | England |
United Kingdom | Leeds Cancer Centre at St. James's University Hospital | Leeds | England |
United Kingdom | Lincoln County Hospital | Lincoln | England |
United Kingdom | Royal Liverpool University Hospital | Liverpool | England |
United Kingdom | Guy's Hospital | London | England |
United Kingdom | Royal Free and UCL Medical School | London | |
United Kingdom | Royal Marsden - London | London | England |
United Kingdom | Saint Bartholomew's Hospital | London | England |
United Kingdom | Macclesfield District General Hospital | Macclesfield | England |
United Kingdom | Paterson Institute for Cancer Research | Manchester | |
United Kingdom | Northwick Park Hospital | Middlesex | |
United Kingdom | School of Surgical & Reproductive Sciences | Newcastle | |
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | |
United Kingdom | Department of General Surgery Pennine Acute Hospitals NHS Trust | Oldham | |
United Kingdom | Derriford Hospital | Plymouth | |
United Kingdom | Cancer Clinical Trials Centre | Sheffield | |
United Kingdom | Weston Park Hospital, Cancer Clinical Trials Centre, Department of Clinical Oncology | Sheffield | |
United Kingdom | Princess Anne Hospital | Southampton | |
United Kingdom | Mid Staffordshire NHS Foundation Trust | Stafford | |
United Kingdom | Singleton Hospital | Swansea | Wales |
United Kingdom | Treliske Royal Cornwall Hospital | Truro | |
United Kingdom | Wishaw General Hospital | Wishaw | |
United Kingdom | Yeovil District Hospital | Yeovil |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
Australia, Belgium, Chile, Denmark, Finland, Germany, Hungary, Ireland, Italy, Malta, Portugal, Switzerland, Turkey, United Kingdom,
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. Erratum in: Lancet. 2014 Mar 22;383(9922):1040. Erratum in: Lancet. 2017 Mar 11;389(10073):1010. — View 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. — View 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. Erratum in: Lancet Oncol. 2014 Dec;15(13):e587. Erratum in: Lancet Oncol. 2014 Dec;15(13):e587. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years | Dec 2013 | ||
Secondary | Breast cancer mortality with median follow-up at 10 years | Dec 2018 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |