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CompletedNCT00072462IBIS-II DCISUpdated Sep 19, 2024Results posted

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

A Phase 3 interventional study of tamoxifen citrate and Anastrozole in Breast Cancer, sponsored by Queen Mary University of London. Completed at 97 sites in 14 countries. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Primary conditionCarcinoma, Intraductal, NoninfiltratingRegistry: Breast NeoplasmsReclassifiedWhy we changed it
Registry
Breast Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma, Intraductal, Noninfiltrating
Why
  1. The study's title name Carcinoma, Intraductal, Noninfiltrating, a narrower term within Breast Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Queen Mary University of London · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,980
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • ductal breast carcinoma in situ
  • breast cancer in situ
03

In context

Carcinoma, Intraductal, Noninfiltrating Reclassified

285 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 54 are open to participants now.

This study's enrollment of 2,980 is above the median of 66 across 207 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.

Browse Carcinoma, Intraductal, Noninfiltrating studies →

Lead sponsor

Queen Mary University of London is the lead sponsor of 253 studies on the registry; 58 are open to participants now.

Browse Queen Mary University of London studies →

Compared within Carcinoma, Intraductal, Noninfiltrating, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
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

  • , 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

  • At least 10 years

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No prior deep vein thrombosis
  • No prior
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,980 participants (actual)

Study arms

  • Active comparator
    Anastrozole

    Drug: Anastrozole

  • Active comparator
    Tamoxifen

    Drug: tamoxifen citrate

Interventions

  • Drugtamoxifen citrate

    Tamoxifen 20mg + Anastrozole placebo

    Also known as: Nolvadex

  • DrugAnastrozole

    Anastrozole 1mg + Tamoxifen placebo

    Also known as: Arimidex

06

What researchers measure

Primary outcomes

  1. Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours

    Time frame: Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Secondary outcomes

  1. Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours

    Time frame: Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

  2. Number of Participants With ER- Breast Cancer Recurrence

    Time frame: Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

  3. Number of Breast Cancer Deaths

    Time frame: Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

  4. Number of Non-breast Cancer Deaths

    Time frame: Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

07

Results

Posted Sep 19, 2024
Limitations and caveats
This CTIMP trial, which recruited between 03 Mar 2003 and 08 Feb 2012, formally ended on 31 May 2021.

Participant flow

Participant flow — Overall Study
MilestoneAnastrozoleTamoxifen
Started14711509
Completed14491489
Not completed2220

Outcome measures

PrimaryNumber of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours
Time frame:
Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reported as:
Count of participants · Participants
Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours
ParticipantsAnastrozoleTamoxifen
Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours103120
Statistical analysis
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.33 · Hazard ratio (hr): 0.88 · 95% CI 0.67 to 1.14Univariate
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.33 · Hazard ratio (hr): 0.87 · 95% CI 0.66 to 1.15Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)
SecondaryNumber of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours
Time frame:
Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reported as:
Count of participants · Participants
Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours
ParticipantsAnastrozoleTamoxifen
Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours5882
Statistical analysis
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.06 · Hazard ratio (hr): 0.72 · 95% CI 0.52 to 1.01Univariate
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.09 · Hazard ratio (hr): 0.74 · 95% CI 0.52 to 1.05Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)
SecondaryNumber of Participants With ER- Breast Cancer Recurrence
Time frame:
Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reported as:
Count of participants · Participants
Number of Participants With ER- Breast Cancer Recurrence
ParticipantsAnastrozoleTamoxifen
Number of Participants With ER- Breast Cancer Recurrence2415
Statistical analysis
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.13 · Hazard ratio (hr): 1.64 · 95% CI 0.75 to 2.84Univariate
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.26 · Hazard ratio (hr): 1.46 · 95% CI 0.75 to 2.84Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)
SecondaryNumber of Breast Cancer Deaths
Time frame:
Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reported as:
Count of participants · Participants
Number of Breast Cancer Deaths
ParticipantsAnastrozoleTamoxifen
Number of Breast Cancer Deaths33
Statistical analysis
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.97 · Hazard ratio (hr): 1.03 · 95% CI 0.21 to 5.11Univariate
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.93 · Hazard ratio (hr): 1.08 · 95% CI 0.22 to 5.36Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)
SecondaryNumber of Non-breast Cancer Deaths
Time frame:
Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reported as:
Count of participants · Participants
Number of Non-breast Cancer Deaths
ParticipantsAnastrozoleTamoxifen
Number of Non-breast Cancer Deaths5965
Statistical analysis
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.67 · Hazard ratio (hr): 0.93 · 95% CI 0.65 to 1.32Univariate
  • Anastrozole vs Tamoxifen · Regression, Cox · p = 0.38 · Hazard ratio (hr): 0.85 · 95% CI 0.59 to 1.22Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)

Adverse events

Collected over Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Anastrozole62/1,449 (4.3%)333/1,449 (23%)1,323/1,449 (91.3%)
Tamoxifen69/1,489 (4.6%)371/1,489 (24.9%)1,380/1,489 (92.7%)
Most frequent serious events
Showing 10 of 547
Most frequent serious events
EventAnastrozoleTamoxifen
OsteoarthritisMusculoskeletal and connective tissue disorders15/144911/1489
Uterine polypReproductive system and breast disorders1/144915/1489
DeathGeneral disorders14/144910/1489
Deep vein thrombosisVascular disorders5/144914/1489
Endometrial hyperplasiaReproductive system and breast disorders1/144912/1489
Ankle fractureInjury, poisoning and procedural complications10/144911/1489
Cerebrovascular accidentNervous system disorders10/14491/1489
Transient ischaemic attackNervous system disorders10/14493/1489
PneumoniaInfections and infestations5/144910/1489
Pulmonary embolismRespiratory, thoracic and mediastinal disorders5/14499/1489
Most frequent other events
Showing 10 of 1,124
Most frequent other events
EventAnastrozoleTamoxifen
Hot flushReproductive system and breast disorders815/1449898/1489
ArthralgiaMusculoskeletal and connective tissue disorders842/1449748/1489
Night sweatsSkin and subcutaneous tissue disorders310/1449341/1489
Vulvovaginal drynessReproductive system and breast disorders201/1449166/1489
Hot flushVascular disorders161/1449184/1489
MalaiseGeneral disorders165/1449177/1489
Vaginal dischargeReproductive system and breast disorders31/1449140/1489
Weight increasedInvestigations126/1449133/1489
MyalgiaMusculoskeletal and connective tissue disorders124/1449106/1489
InsomniaPsychiatric disorders109/144993/1489

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)AnastrozoleTamoxifenTotal
<=18 years000
Between 18 and 65 years113911712310
>=65 years332338670
Age, Continuous
Age, Continuous(years)AnastrozoleTamoxifenTotal
Median60.4 (56.4 to 64.7)60.3 (55.8 to 64.5)60.3 (56.1 to 64.6)
Sex: Female, Male
Sex: Female, Male(Participants)AnastrozoleTamoxifenTotal
Female147115092980
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)AnastrozoleTamoxifenTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)AnastrozoleTamoxifenTotal
Sweden448
United Kingdom429460889
Italy165158323
Australia7692168
Switzerland192645
Belgium5450104
Chile9817
Finland437
Ireland423678
France211215426
Germany386393779
Hungary7815
Malta224
New Zealand4610
Turkey7815
Austria513990
India112
08

Study locations

97 sites
  • Australia
    Newcastle, Australia
  • Austrian Breast & Colorectal Cancer Study Group
    Vienna, Austria
  • Belgium
    Leuven, Belgium
  • Chile
    Santiago, Chile
  • Institut Sainte Catherine
    Avignon, 84082, France
  • Institut Bergonie
    Bordeaux, 33076, France
  • Polyclinique Bordeaux Nord Aquitaine
    Bordeaux, 33300, France
  • Clinique Tivoli
    Bordeaux, F-33000, France
  • CHU Hopital A. Morvan
    Brest, 29609, France
  • Centre Regional Francois Baclesse
    Caen, 14076, France
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
    Dijon, 21079, France
  • Centre Hospitalier de Lagny
    Lagny Sur Marne, 77405, France
  • CMC Les Ormeaux
    Le Havre, 76600, France
  • Centre Oscar Lambret
    Lille, 59020, France
  • Centre Hospital Regional Universitaire de Limoges
    Limoges, 87042, France
  • Centre Hospitalier de Mulhouse
    Mulhouse, 68051, France
  • Centre Regional Rene Gauducheau
    Nantes, 44805, France
  • Clinique Saint - Pierre
    Perpignan, France
  • Institut Jean Godinot
    Reims, 51056, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • Centre Henri Becquerel
    Rouen, 76038, France
  • Institut Claudius Regaud
    Toulouse, 31052, France
  • Institut Gustave Roussy
    Villejuif, F-94805, France
  • Germany
    Neu-Isenburg, Germany
  • Hungary
    Szeged, Hungary
  • Cork Infirmary
    Cork, Ireland
  • Cork University Hospital
    Cork, Ireland
  • Beaumont Hospital
    Dublin, Ireland
  • St. Vincent's University Hospital
    Dublin, Ireland
  • University College Hospital
    Galway, Ireland
  • Mid-Western Regional Hospital
    Limerick, Ireland
  • Sligo General Hospital
    Sligo, Ireland
  • The Adelaide and Meath Hospital
    Tallaght, Ireland
  • European Institute of Oncology
    Milan, Italy
  • Sir Paul Boffa Hospital,
    Floriana, Malta
  • Sweden
    Lund, Sweden
  • Switzerland(St. Gallen)
    (St. Gallen), Switzerland
  • Inselspital Bern
    Bern, CH-3010, Switzerland
  • Oncocare Sonnenhof-Klinik Engeriedspital
    Bern, CH-3012, Switzerland
  • Hopital Cantonal Universitaire de Geneve
    Geneva, CH-1211, Switzerland
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, CH-1011, Switzerland
  • Kantonspital
    Luzern, CH-6000, Switzerland
  • Ospedale Beata Vergine
    Mendrisio, CH-6850, Switzerland
  • Tumor Zentrum ZeTup St. Gallen und Chur
    St. Gallen, CH-9006, Switzerland
  • Regionalspital
    Thun, 3600, Switzerland
  • Turkey(Istanbul University)
    Istanbul, Turkey
  • Frenchay Hospital
    Bristol, England BS16 1LE, United Kingdom
  • Colchester General Hospital
    Colchester, England CO4 5JL, United Kingdom
  • Leeds Cancer Centre at St. James's University Hospital
    Leeds, England LS9 7TF, United Kingdom
  • Royal Liverpool University Hospital
    Liverpool, England L7 8XP, United Kingdom
  • Whittington Hospital
    London, England N19 5NF, United Kingdom
  • St. Thomas' Hospital
    London, England SE1 9RT, United Kingdom
  • Christie Hospital
    Manchester, England M20 4BX, United Kingdom
  • Newcastle Upon Tyne Hospitals NHS Trust
    Newcastle-Upon-Tyne, England NE1 4LP, United Kingdom
  • Nottingham City Hospital
    Nottingham, England NG5 1PB, United Kingdom
  • Royal South Hants Hospital
    Southampton, England SO14 0YG, United Kingdom
  • Centre for Cancer Research and Cell Biology at Queen's University Belfast
    Belfast, Northern Ireland BT9 7AB, United Kingdom
  • St. Bartholomew's Hospital
    London, Please Select EC1A 7BE, United Kingdom
  • Royal Marsden Hospital
    London, Please Select SW3 6JJ, United Kingdom
  • Ninewells Hospital
    Dundee, Scotland DD1 9SY, United Kingdom
  • Royal Infirmary of Edinburgh at Little France
    Edinburgh, Scotland EH3 9YW, United Kingdom
  • University Hospital of Wales
    Cardiff, Wales CF14 4XN, United Kingdom
  • Aberdeen Royal Infirmary
    Aberdeen, AB25 2ZA, United Kingdom
  • Tameside General Hospital
    Ashton under Lyne, OL6 9RW, United Kingdom
  • Royal Bolton Hospital
    Bolton, BL4 0JR, United Kingdom
  • Royal Bournemouth Hospital
    Bournemouth, BH7 7DW, United Kingdom
  • St Lukes Hospital
    Bradford, BD5 0NA, United Kingdom
  • Royal Sussex County Hospital
    Brighton, BN2 5BE, United Kingdom
  • Bristol Infirmary
    Bristol, BS2 8ED, United Kingdom
  • Queens Hospital Burton
    Burton, DE13 0RB, United Kingdom
  • Cheltenham General Hospital
    Cheltenham, GL53 7AN, United Kingdom
  • Countess of Chester Hospital
    Chester, CH2 1UL, United Kingdom
  • Derbyshire Royal Infirmary
    Derby, DE1 2QY, United Kingdom
  • St Margaret's Hospital
    Epping, CM16 6TN, United Kingdom
  • Royal Devon and Exeter Hospital
    Exeter, EX2 5DW, United Kingdom
  • Frimley Park Hospital NHS Trust
    Frimley, GU16 7UJ, United Kingdom
  • Grantham & District Hospital
    Grantham, NG31 8NG, United Kingdom
  • Conquest Hospital, The Ridge
    Hastings, TN37 7RD, United Kingdom
  • Huddersfield Royal Infirmary
    Huddersfield, HD3 3EA, United Kingdom
  • Castle Hill Hospital
    Hull, HU16 5JQ, United Kingdom
  • Airedale General Hospital
    Keighley, BD20 6TD, United Kingdom
  • Leeds St James.
    Leeds, LS9 7TF, United Kingdom
  • Lincoln County Hospital
    Lincoln, LN2 5QY, United Kingdom
  • Derriford Hospital
    Plymouth, PL6 8BX, United Kingdom
  • Royal Hospital Haslar
    Portsmouth, PO12 2AA, United Kingdom
  • Scarborough NHS Trust
    Scarborough, YO12 6QL, United Kingdom
  • Weston Park Hospital
    Sheffield, S10 2SJ, United Kingdom
  • Staffordshire General Hospital
    Stafford, ST16 3SA, United Kingdom
  • Singleton Hospital
    Swansea, SA2 8QA, United Kingdom
  • Treliske Royal Cornwall Hospital
    Truro, TR1 3LJ, United Kingdom
  • Clayton Hospital, Northgate
    Wakefield, WF1 3JS, United Kingdom
  • Welwyn Garden City Hospital
    Welwyn, AL7 4HQ, United Kingdom
  • Wishaw General Hospital
    Wishaw, ML2 0DP, United Kingdom
  • Worthing Hospital
    Worthing, BN11 2DH, United Kingdom
  • Yeovil District Hospital
    Yeovil, BA21 4AT, United Kingdom
  • York Hospital
    York, YO31 8HE, United Kingdom
09

References and documents

Publications

  • 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. PubMed 18816321 ↗
  • 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. PubMed 26686313 ↗
  • 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. PubMed 29126161 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00072462
Lead sponsor
Queen Mary University of London
Collaborators
Cancer Research UK
Responsible party
Sponsor
First posted
Nov 6, 2003
Start date
Sep 2003
Primary completion
Dec 2015
Completion
May 31, 2021
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

Jack Cuzick, PhD
study chair · Queen Mary University of London
Anthony Howell
study chair · University of Manchester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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