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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
anastrozole
placebo
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, chemoprevention

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Newcastle Mater Hospital
  • University Hospitals
  • Corporacion Nacional del Cancer
  • Herlev University Hospital
  • Pirkanmaa Cancer Society
  • GBG Forschungs GMBH
  • Department of Oncotherapy, University of Szeged
  • Beaumont Hospital
  • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
  • Cork University Hospital
  • South Infirmary Victoria Hospital
  • St. Vincent's University Hospital
  • St. James's Hospital
  • University College Hospital
  • Mid-Western Cancer Centre at Mid-Western Regional Hospital
  • Sligo General Hospital
  • Division of Chemoprevention
  • Sir Paul Boffa Hospital, Harper Lane
  • Instituto Portugues De Oncologia, Gabinete De Estudos Clinicos
  • Inselspital Bern
  • Oncocare Sonnenhof-Klinik Engeriedspital
  • Hopital Cantonal Universitaire de Geneve
  • Ospedale Beata Vergine
  • Tumor Zentrum ZeTup St. Gallen und Chur
  • Regionalspital
  • Ortaklar cad Pehlivan sok, Basak koviah ap.
  • Tameside General Hospital
  • Royal Bolton Hospital
  • Royal Bournemouth Hospital
  • St. Luke's Hospital
  • Sussex Cancer Centre at Royal Sussex County Hospital
  • Frenchay Hospital
  • Bristol Royal Infirmary
  • Queen's Hospital
  • Broomfield Hospital
  • Gloucestershire Oncology Centre at Cheltenham General Hospital
  • Countess of Chester Hospital
  • Essex County Hospital
  • Royal Derby Hospital
  • Saint Margaret's Hospital,
  • Royal Devon and Exeter Hospital
  • Frimley Park Hospital
  • Conquest Hospital
  • Castle Hill Hospital
  • Airedale General Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Lincoln County Hospital
  • Royal Liverpool University Hospital
  • Saint Bartholomew's Hospital
  • Guy's Hospital
  • Royal Marsden - London
  • Macclesfield District General Hospital
  • Centre for Cancer Research and Cell Biology at Queen's University Belfast
  • Ninewells Hospital
  • Edinburgh Cancer Centre at Western General Hospital
  • University Hospital of Wales
  • Singleton Hospital
  • Aberdeen Royal Infirmary
  • Lincoln County Hospital
  • Calderdale Royal Hospital
  • Royal Free and UCL Medical School
  • Paterson Institute for Cancer Research
  • Northwick Park Hospital
  • School of Surgical & Reproductive Sciences
  • Nottingham University Hospitals NHS Trust
  • Department of General Surgery Pennine Acute Hospitals NHS Trust
  • Derriford Hospital
  • Cancer Clinical Trials Centre
  • Weston Park Hospital, Cancer Clinical Trials Centre, Department of Clinical Oncology
  • Princess Anne Hospital
  • Mid Staffordshire NHS Foundation Trust
  • Treliske Royal Cornwall Hospital
  • Wishaw General Hospital
  • Yeovil District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

anastrozole

placebo

Arm Description

anastrozole 1mg

anastrozole 1mg PLACEBO

Outcomes

Primary Outcome Measures

Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years

Secondary Outcome Measures

Breast cancer mortality with median follow-up at 10 years

Full Information

First Posted
March 8, 2004
Last Updated
October 5, 2021
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00078832
Brief Title
Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
Acronym
IBIS II
Official Title
International Breast Cancer Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, chemoprevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3864 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anastrozole
Arm Type
Experimental
Arm Description
anastrozole 1mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
anastrozole 1mg PLACEBO
Intervention Type
Drug
Intervention Name(s)
anastrozole
Other Intervention Name(s)
Arimidex
Intervention Description
aromatase inhibitor
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Arimidex placebo
Primary Outcome Measure Information:
Title
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
Time Frame
Dec 2013
Secondary Outcome Measure Information:
Title
Breast cancer mortality with median follow-up at 10 years
Time Frame
Dec 2018

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Cuzick, PhD
Organizational Affiliation
Queen Mary University of London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anthony Howell
Organizational Affiliation
University of Manchester
Official's Role
Study Chair
Facility Information:
Facility Name
Newcastle Mater Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2310
Country
Australia
Facility Name
University Hospitals
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Corporacion Nacional del Cancer
City
Santiago
Country
Chile
Facility Name
Herlev University Hospital
City
Horsholm
ZIP/Postal Code
Dk- 2730 Herlev
Country
Denmark
Facility Name
Pirkanmaa Cancer Society
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
GBG Forschungs GMBH
City
Frankfurt
ZIP/Postal Code
63263
Country
Germany
Facility Name
Department of Oncotherapy, University of Szeged
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Beaumont Hospital
City
Dublin
State/Province
Beaumont
ZIP/Postal Code
9
Country
Ireland
Facility Name
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
City
Dublin
State/Province
Tallaght
ZIP/Postal Code
24
Country
Ireland
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
South Infirmary Victoria Hospital
City
Cork
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
University College Hospital
City
Galway
Country
Ireland
Facility Name
Mid-Western Cancer Centre at Mid-Western Regional Hospital
City
Limerick
ZIP/Postal Code
0009
Country
Ireland
Facility Name
Sligo General Hospital
City
Sligo
Country
Ireland
Facility Name
Division of Chemoprevention
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Sir Paul Boffa Hospital, Harper Lane
City
Floriana
ZIP/Postal Code
VLT 14
Country
Malta
Facility Name
Instituto Portugues De Oncologia, Gabinete De Estudos Clinicos
City
Lisbon
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Oncocare Sonnenhof-Klinik Engeriedspital
City
Bern
ZIP/Postal Code
CH-3012
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Ospedale Beata Vergine
City
Mendrisio
ZIP/Postal Code
CH-6850
Country
Switzerland
Facility Name
Tumor Zentrum ZeTup St. Gallen und Chur
City
St. Gallen
ZIP/Postal Code
CH-9006
Country
Switzerland
Facility Name
Regionalspital
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
Ortaklar cad Pehlivan sok, Basak koviah ap.
City
Istanbul
Country
Turkey
Facility Name
Tameside General Hospital
City
Ashton-Under-Lyne
State/Province
England
ZIP/Postal Code
OL6 9RW
Country
United Kingdom
Facility Name
Royal Bolton Hospital
City
Bolton
State/Province
England
ZIP/Postal Code
BL4 0JR
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
England
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
St. Luke's Hospital
City
Bradford
State/Province
England
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Frenchay Hospital
City
Bristol
State/Province
England
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Queen's Hospital
City
Burton-upon-Trent
State/Province
England
ZIP/Postal Code
DE13 0RB
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford
State/Province
England
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Gloucestershire Oncology Centre at Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Countess of Chester Hospital
City
Chester
State/Province
England
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
C03 3NB
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Saint Margaret's Hospital,
City
Epping
State/Province
England
ZIP/Postal Code
CM16 6TN
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Frimley Park Hospital
City
Frimley
State/Province
England
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Conquest Hospital
City
Hastings
State/Province
England
ZIP/Postal Code
TN37 7RD
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Hull
State/Province
England
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Airedale General Hospital
City
Keighley
State/Province
England
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
State/Province
England
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Macclesfield District General Hospital
City
Macclesfield
State/Province
England
ZIP/Postal Code
SK10 3BL
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Queen's University Belfast
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZA
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Grantham
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Calderdale Royal Hospital
City
Huddersfield
ZIP/Postal Code
HX3 0PW
Country
United Kingdom
Facility Name
Royal Free and UCL Medical School
City
London
ZIP/Postal Code
N19 5LW
Country
United Kingdom
Facility Name
Paterson Institute for Cancer Research
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
School of Surgical & Reproductive Sciences
City
Newcastle
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Department of General Surgery Pennine Acute Hospitals NHS Trust
City
Oldham
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Cancer Clinical Trials Centre
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Weston Park Hospital, Cancer Clinical Trials Centre, Department of Clinical Oncology
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Princess Anne Hospital
City
Southampton
ZIP/Postal Code
SO16 5YA
Country
United Kingdom
Facility Name
Mid Staffordshire NHS Foundation Trust
City
Stafford
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
Facility Name
Treliske Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
ZIP/Postal Code
BA21 4AT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25456365
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. Lancet Oncol. 2014 Dec;15(13):e587.
Results Reference
background
PubMed Identifier
18768369
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.
Results Reference
background
PubMed Identifier
29126161
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.
Results Reference
background
PubMed Identifier
24333009
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. Erratum In: Lancet. 2014 Mar 22;383(9922):1040. Lancet. 2017 Mar 11;389(10073):1010.
Results Reference
background
Links:
URL
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-anastrozole-to-prevent-breast-cancer-in-postmenopausal-women
Description
Clinical trial summary from Cancer Research UK Website
URL
https://www.ibis-trials.org/thetrials/ibistrials/ibis-2-prevention
Description
IBIS-II website

Learn more about this trial

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

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