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AzTrials

Breast CancerPhase 3IBIS-II DCISNCT00072462

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

A Phase 3 study testing tamoxifen citrate and Anastrozole in people with Breast Cancer, run by Queen Mary University of London at 97 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
tamoxifen citrate and Anastrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,980 participants
Where
97 sitesin 14 countries
Study dates
Sep 2003to 31 May 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

97 sites in 14 countries.

97 sites in 14 countries

United Kingdom50 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZA

  • Tameside General Hospital

    Ashton-under-Lyne, OL6 9RW

  • Centre for Cancer Research and Cell Biology at Queen's University Belfast

    Belfast, Northern Ireland, BT9 7AB

  • Royal Bolton Hospital

    Bolton, BL4 0JR

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • St Lukes Hospital

    Bradford, BD5 0NA

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Frenchay Hospital

    Bristol, England, BS16 1LE

  • Bristol Infirmary

    Bristol, BS2 8ED

  • Queens Hospital Burton

    Burton, DE13 0RB

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XN

  • Cheltenham General Hospital

    Cheltenham, GL53 7AN

  • Countess of Chester Hospital

    Chester, CH2 1UL

  • Colchester General Hospital

    Colchester, England, CO4 5JL

  • Derbyshire Royal Infirmary

    Derby, DE1 2QY

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Royal Infirmary of Edinburgh at Little France

    Edinburgh, Scotland, EH3 9YW

  • St Margaret's Hospital

    Epping, CM16 6TN

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Frimley Park Hospital NHS Trust

    Frimley, GU16 7UJ

  • Grantham & District Hospital

    Grantham, NG31 8NG

  • Conquest Hospital, The Ridge

    Hastings, TN37 7RD

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • Castle Hill Hospital

    Hull, HU16 5JQ

  • Airedale General Hospital

    Keighley, BD20 6TD

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Leeds St James.

    Leeds, LS9 7TF

  • Lincoln County Hospital

    Lincoln, LN2 5QY

  • Royal Liverpool University Hospital

    Liverpool, England, L7 8XP

  • Whittington Hospital

    London, England, N19 5NF

  • St. Thomas' Hospital

    London, England, SE1 9RT

  • St. Bartholomew's Hospital

    London, Please Select, EC1A 7BE

  • Royal Marsden Hospital

    London, Please Select, SW3 6JJ

  • Christie Hospital

    Manchester, England, M20 4BX

  • Newcastle Upon Tyne Hospitals NHS Trust

    Newcastle upon Tyne, England, NE1 4LP

  • Nottingham City Hospital

    Nottingham, England, NG5 1PB

  • Derriford Hospital

    Plymouth, PL6 8BX

  • Royal Hospital Haslar

    Portsmouth, PO12 2AA

  • Scarborough NHS Trust

    Scarborough, YO12 6QL

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Royal South Hants Hospital

    Southampton, England, SO14 0YG

  • Staffordshire General Hospital

    Stafford, ST16 3SA

  • Singleton Hospital

    Swansea, SA2 8QA

  • Treliske Royal Cornwall Hospital

    Truro, TR1 3LJ

  • Clayton Hospital, Northgate

    Wakefield, WF1 3JS

  • Welwyn Garden City Hospital

    Welwyn, AL7 4HQ

  • Wishaw General Hospital

    Wishaw, ML2 0DP

  • Worthing Hospital

    Worthing, BN11 2DH

  • Yeovil District Hospital

    Yeovil, BA21 4AT

  • York Hospital

    York, YO31 8HE

Other trials in United Kingdom

France20 sites

  • Institut Sainte Catherine

    Avignon, 84082

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Clinique Tivoli

    Bordeaux, F-33000

  • CHU Hopital A. Morvan

    Brest, 29609

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospitalier de Lagny

    Lagny-sur-Marne, 77405

  • CMC Les Ormeaux

    Le Havre, 76600

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • Centre Regional Rene Gauducheau

    Nantes, 44805

  • Clinique Saint - Pierre

    Perpignan

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Claudius Regaud

    Toulouse, 31052

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Switzerland9 sites

  • Inselspital Bern

    Bern, CH-3010

  • Oncocare Sonnenhof-Klinik Engeriedspital

    Bern, CH-3012

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonspital

    Lucerne, CH-6000

  • Ospedale Beata Vergine

    Mendrisio, CH-6850

  • Tumor Zentrum ZeTup St. Gallen und Chur

    Sankt Gallen, CH-9006

  • Switzerland(St. Gallen)

    Sankt Gallen

  • Regionalspital

    Thun, 3600

Other trials in Switzerland

Ireland8 sites

  • Cork Infirmary

    Cork

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin

  • St. Vincent's University Hospital

    Dublin

  • University College Hospital

    Galway

  • Mid-Western Regional Hospital

    Limerick

  • Sligo General Hospital

    Sligo

  • The Adelaide and Meath Hospital

    Tallaght

Other trials in Ireland

Australia1 site

  • Australia

    Newcastle

Other trials in Australia

Austria1 site

  • Austrian Breast & Colorectal Cancer Study Group

    Vienna

Other trials in Austria

Belgium1 site

  • Belgium

    Leuven

Other trials in Belgium

Chile1 site

  • Chile

    Santiago

Other trials in Chile

Germany1 site

  • Germany

    Neu-Isenburg

Other trials in Germany

Hungary1 site

  • Hungary

    Szeged

Other trials in Hungary

Italy1 site

  • European Institute of Oncology

    Milan

Other trials in Italy

Malta1 site

  • Sir Paul Boffa Hospital,

    Floriana

Other trials in Malta

Sweden1 site

  • Sweden

    Lund

Other trials in Sweden

Turkey (Türkiye)1 site

  • Turkey(Istanbul University)

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: International Breast Cancer Intervention Study II (IBIS-II) (DCIS)

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.

Conditions
Breast Cancer
Being tested
tamoxifen citrate, Anastrozole
Keywords
ductal breast carcinoma in situ, breast cancer in situ
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tamoxifen citrateDrug

    Also called Nolvadex

    Tamoxifen 20mg + Anastrozole placebo

  • AnastrozoleDrug

    Also called Arimidex

    Anastrozole 1mg + Tamoxifen placebo

Study groups in NCT00072462
Study groupRoleWhat they receive
AnastrozoleActive comparatorNot described
Receives: Drug: Anastrozole
TamoxifenActive comparatorNot described
Receives: Drug: tamoxifen citrate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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 (4)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionDec 2015
  4. Study completion31 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,980 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072462
Sponsor's protocol ID
ISRCTN37546358
Other IDs
EU-20226, BIG-5-02, IBCSG-31-03-DCIS, ISRCTN31488319
Acronym
IBIS-II DCIS
Status last verified
Apr 2024
First submitted
4 Nov 2003
Last updated
19 Sep 2024
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tamoxifen citrate and Anastrozole in people with Breast Cancer, run by Queen Mary University of London at 97 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United Kingdom, France, Switzerland, Ireland, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00072462, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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