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Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ (IBIS-II DCIS)

Primary Purpose

Breast Cancer

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

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring ductal breast carcinoma in situ, breast cancer in situ

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of ductal carcinoma in situ within the past 6 months Locally excised with tumor-free margins at least 1 mm Hormone receptor status: Estrogen or progesterone receptor positive Equal to or greater than 5% positive cells PATIENT CHARACTERISTICS: Age 40 to 70 Sex Female Menopausal status Postmenopausal, defined as meeting at least 1 of the following criteria: Over age 60 Prior bilateral oophorectomy Age 60 or under with a uterus AND amenorrhea for at least the past 12 months Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L Performance status Not specified Life expectancy At least 10 years Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No prior deep vein thrombosis No prior transient ischemic attack No prior cerebrovascular accident Pulmonary No prior pulmonary embolism Other No unexplained postmenopausal bleeding No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results No evidence of osteoporosis Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures Psychologically and physically suitable for 5 years of study therapy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at least 5 years. No prior or concurrent raloxifene use lasting more than 6 months unless treatment was completed more than 5 years ago. No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months unless treatment was completed more than 5 years ago No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations Radiotherapy Not specified Surgery See Disease Characteristics No prior mastectomy No planned prophylactic mastectomy Other At least 3 months since prior unapproved or experimental agents No concurrent anticoagulants

Sites / Locations

  • Australia
  • Austrian Breast & Colorectal Cancer Study Group
  • Belgium
  • Chile
  • Institut Sainte Catherine
  • Institut Bergonie
  • Polyclinique Bordeaux Nord Aquitaine
  • Clinique Tivoli
  • CHU Hopital A. Morvan
  • Centre Regional Francois Baclesse
  • Centre Jean Perrin
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • Centre Hospitalier de Lagny
  • CMC Les Ormeaux
  • Centre Oscar Lambret
  • Centre Hospital Regional Universitaire de Limoges
  • Centre Hospitalier de Mulhouse
  • Centre Regional Rene Gauducheau
  • Clinique Saint - Pierre
  • Institut Jean Godinot
  • Centre Eugene Marquis
  • Centre Henri Becquerel
  • Institut Claudius Regaud
  • Institut Gustave Roussy
  • Germany
  • Hungary
  • Cork Infirmary
  • Cork University Hospital
  • Beaumont Hospital
  • St. Vincent's University Hospital
  • University College Hospital
  • Mid-Western Regional Hospital
  • Sligo General Hospital
  • The Adelaide and Meath Hospital
  • European Institute of Oncology
  • Sir Paul Boffa Hospital,
  • Sweden
  • Switzerland(St. Gallen)
  • Inselspital Bern
  • Oncocare Sonnenhof-Klinik Engeriedspital
  • Hopital Cantonal Universitaire de Geneve
  • Centre Hospitalier Universitaire Vaudois
  • Kantonspital
  • Ospedale Beata Vergine
  • Tumor Zentrum ZeTup St. Gallen und Chur
  • Regionalspital
  • Turkey(Istanbul University)
  • Frenchay Hospital
  • Colchester General Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Royal Liverpool University Hospital
  • Whittington Hospital
  • St. Thomas' Hospital
  • Christie Hospital
  • Newcastle Upon Tyne Hospitals NHS Trust
  • Nottingham City Hospital
  • Royal South Hants Hospital
  • Centre for Cancer Research and Cell Biology at Queen's University Belfast
  • St. Bartholomew's Hospital
  • Royal Marsden Hospital
  • Ninewells Hospital
  • Royal Infirmary of Edinburgh at Little France
  • University Hospital of Wales
  • Aberdeen Royal Infirmary
  • Tameside General Hospital
  • Royal Bolton Hospital
  • Royal Bournemouth Hospital
  • St Lukes Hospital
  • Royal Sussex County Hospital
  • Bristol Infirmary
  • Queens Hospital Burton
  • Cheltenham General Hospital
  • Countess of Chester Hospital
  • Derbyshire Royal Infirmary
  • St Margaret's Hospital
  • Royal Devon and Exeter Hospital
  • Frimley Park Hospital NHS Trust
  • Grantham & District Hospital
  • Conquest Hospital, The Ridge
  • Huddersfield Royal Infirmary
  • Castle Hill Hospital
  • Airedale General Hospital
  • Leeds St James.
  • Lincoln County Hospital
  • Derriford Hospital
  • Royal Hospital Haslar
  • Scarborough NHS Trust
  • Weston Park Hospital
  • Staffordshire General Hospital
  • Singleton Hospital
  • Treliske Royal Cornwall Hospital
  • Clayton Hospital, Northgate
  • Welwyn Garden City Hospital
  • Wishaw General Hospital
  • Worthing Hospital
  • Yeovil District Hospital
  • York Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anastrozole

Tamoxifen

Arm Description

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

To examine the effect of tamoxifen vs anastrozole on breast cancer mortality

Full Information

First Posted
November 4, 2003
Last Updated
October 5, 2021
Sponsor
Queen Mary University of London
Collaborators
Cancer Research UK
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1. Study Identification

Unique Protocol Identification Number
NCT00072462
Brief Title
Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
Acronym
IBIS-II DCIS
Official Title
International Breast Cancer Intervention Study II (IBIS-II) (DCIS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2015 (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
Collaborators
Cancer Research UK

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.
Detailed Description
OBJECTIVES: Primary Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ. Compare side effect profiles of these drugs in these patients. Secondary Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients. Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients. Compare breast cancer mortality in patients treated with these drugs. Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients. Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs. OUTLINE: This is a randomized, double-blind, multicentre study. Patients are stratified according to participating centre. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral tamoxifen and oral placebo once daily. Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity. Patients are followed annually for 5 years and a further 5 years (minimum) off treatment. Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2980 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anastrozole
Arm Type
Active Comparator
Arm Title
Tamoxifen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Other Intervention Name(s)
Nolvadex
Intervention Description
Tamoxifen 20mg + Anastrozole placebo
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Other Intervention Name(s)
Arimidex
Intervention Description
Anastrozole 1mg + Tamoxifen 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
2 years
Secondary Outcome Measure Information:
Title
To examine the effect of tamoxifen vs anastrozole on breast cancer mortality
Time Frame
7 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of ductal carcinoma in situ within the past 6 months Locally excised with tumor-free margins at least 1 mm Hormone receptor status: Estrogen or progesterone receptor positive Equal to or greater than 5% positive cells PATIENT CHARACTERISTICS: Age 40 to 70 Sex Female Menopausal status Postmenopausal, defined as meeting at least 1 of the following criteria: Over age 60 Prior bilateral oophorectomy Age 60 or under with a uterus AND amenorrhea for at least the past 12 months Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L Performance status Not specified Life expectancy At least 10 years Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No prior deep vein thrombosis No prior transient ischemic attack No prior cerebrovascular accident Pulmonary No prior pulmonary embolism Other No unexplained postmenopausal bleeding No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results No evidence of osteoporosis Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures Psychologically and physically suitable for 5 years of study therapy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at least 5 years. No prior or concurrent raloxifene use lasting more than 6 months unless treatment was completed more than 5 years ago. No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months unless treatment was completed more than 5 years ago No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations Radiotherapy Not specified Surgery See Disease Characteristics No prior mastectomy No planned prophylactic mastectomy Other At least 3 months since prior unapproved or experimental agents No concurrent anticoagulants
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
Australia
City
Newcastle
Country
Australia
Facility Name
Austrian Breast & Colorectal Cancer Study Group
City
Vienna
Country
Austria
Facility Name
Belgium
City
Leuven
Country
Belgium
Facility Name
Chile
City
Santiago
Country
Chile
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Clinique Tivoli
City
Bordeaux
ZIP/Postal Code
F-33000
Country
France
Facility Name
CHU Hopital A. Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier de Lagny
City
Lagny Sur Marne
ZIP/Postal Code
77405
Country
France
Facility Name
CMC Les Ormeaux
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Clinique Saint - Pierre
City
Perpignan
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Germany
City
Neu-Isenburg
Country
Germany
Facility Name
Hungary
City
Szeged
Country
Hungary
Facility Name
Cork Infirmary
City
Cork
Country
Ireland
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
University College Hospital
City
Galway
Country
Ireland
Facility Name
Mid-Western Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Sligo General Hospital
City
Sligo
Country
Ireland
Facility Name
The Adelaide and Meath Hospital
City
Tallaght
Country
Ireland
Facility Name
European Institute of Oncology
City
Milan
Country
Italy
Facility Name
Sir Paul Boffa Hospital,
City
Floriana
Country
Malta
Facility Name
Sweden
City
Lund
Country
Sweden
Facility Name
Switzerland(St. Gallen)
City
(St. Gallen)
Country
Switzerland
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
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonspital
City
Luzern
ZIP/Postal Code
CH-6000
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
Turkey(Istanbul University)
City
Istanbul
Country
Turkey
Facility Name
Frenchay Hospital
City
Bristol
State/Province
England
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Colchester General Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
CO4 5JL
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
Royal Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Whittington Hospital
City
London
State/Province
England
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals NHS Trust
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
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
St. Bartholomew's Hospital
City
London
State/Province
Please Select
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
State/Province
Please Select
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh at Little France
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH3 9YW
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZA
Country
United Kingdom
Facility Name
Tameside General Hospital
City
Ashton under Lyne
ZIP/Postal Code
OL6 9RW
Country
United Kingdom
Facility Name
Royal Bolton Hospital
City
Bolton
ZIP/Postal Code
BL4 0JR
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
St Lukes Hospital
City
Bradford
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Bristol Infirmary
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Queens Hospital Burton
City
Burton
ZIP/Postal Code
DE13 0RB
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Countess of Chester Hospital
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
St Margaret's Hospital
City
Epping
ZIP/Postal Code
CM16 6TN
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Frimley Park Hospital NHS Trust
City
Frimley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Grantham & District Hospital
City
Grantham
ZIP/Postal Code
NG31 8NG
Country
United Kingdom
Facility Name
Conquest Hospital, The Ridge
City
Hastings
ZIP/Postal Code
TN37 7RD
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Airedale General Hospital
City
Keighley
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
Facility Name
Leeds St James.
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BX
Country
United Kingdom
Facility Name
Royal Hospital Haslar
City
Portsmouth
ZIP/Postal Code
PO12 2AA
Country
United Kingdom
Facility Name
Scarborough NHS Trust
City
Scarborough
ZIP/Postal Code
YO12 6QL
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Staffordshire General Hospital
City
Stafford
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Treliske Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Clayton Hospital, Northgate
City
Wakefield
ZIP/Postal Code
WF1 3JS
Country
United Kingdom
Facility Name
Welwyn Garden City Hospital
City
Welwyn
ZIP/Postal Code
AL7 4HQ
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
York Hospital
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18816321
Citation
Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF. Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect. 2008 Sep;11(3):252-62. doi: 10.1111/j.1369-7625.2008.00498.x.
Results Reference
background
PubMed Identifier
26686313
Citation
Forbes JF, Sestak I, Howell A, Bonanni B, Bundred N, Levy C, von Minckwitz G, Eiermann W, Neven P, Stierer M, Holcombe C, Coleman RE, Jones L, Ellis I, Cuzick J; IBIS-II investigators. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. Lancet. 2016 Feb 27;387(10021):866-73. doi: 10.1016/S0140-6736(15)01129-0. Epub 2015 Dec 11.
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
Links:
URL
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-tamoxifen-or-anastrozole-in-postmenopausal-women-with-ductal-carcinoma-in-situ-of-the-breast
Description
Clinical trial summary from Cancer Research UK Website
URL
https://www.ibis-trials.org/thetrials/ibistrials/ibis-2-dcis
Description
IBIS-II website

Learn more about this trial

Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

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