Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Adjuvant Tamoxifen Versus Anastrozole in Postmenopausal Women With Ductal Carcinoma In Situ

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	40 to 70	Other	CRUK-IBIS-II-DCIS EU-20226, BIG-5-02, NCT00072462, IBCSG-31-03-DCIS, ISRCTN31488319

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• 40-70 years old
• No more than 6 months since diagnosis of ductal carcinoma in situ
• No previous mastectomy
• No scheduled prophylactic mastectomy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive tamoxifen by mouth and a placebo by mouth once a day. Patients in group two will receive anastrozole by mouth and a placebo by mouth once a day. Treatment in both groups may continue for up to 5 years. Patients will be evaluated once a year for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Cancer Research UK at Imperial College School of Medicine - London

Jack Cuzick, PhD, Study coordinator		Ph: 44-20-7269-3006

International Breast Cancer Study Group

Katharina Buser, MD, Protocol chair		Ph: 41-31-309-9501 Email: kbuser@sonnenhof.ch

France
	Avignon
	Institut Sainte Catherine
		Daniel Serin, MD	Ph:  33-490-276-263
			Email: d.serin@isc84.org
	Bordeaux
	Clinique Tivoli
		Dominique Jaubert, MD	Ph:  33-556-116-087
			Email: dominique.jaubert@wanadoo.fr
	Institut Bergonie
		Christine Tunon-de-Lara, MD	Ph:  33-556-333-333
			Email: tunon@bergonie.org
	Polyclinique Bordeaux Nord Aquitaine
		Nadine Dohollor	Ph:  33-556-437-354
	Brest
	CHU Hopital A. Morvan
		Helene Simon-Swirsky, MD	Ph:  33-298-223-395
	Caen
	Centre Regional Francois Baclesse
		Thierry Delozier, MD	Ph:  33-23-145-5015
			Email: t.delozier@baclesse.fr
	Clermont-Ferrand
	Centre Jean Perrin
		Herve Cure, MD, PhD	Ph:  33-4-73-278-137
	Dijon
	Centre de Lutte Contre le Cancer Georges-Francois Leclerc
		Jean Cuisenier, MD	Ph:  33-3-8073-7508
			Email: jcuisenier@dijon.fnclcc.fr
	La Roche Sur Yon
	Centre Hospitalier Departemental
		Mohamad-Ayman Zawadi, MD	Ph:  33-2-5144-6317
	Lagny Sur Marne
	Centre Hospitalier de Lagny
		Daniele Chevallier	Ph:  33-64-307-213
	Le Havre
	CMC Les Ormeaux
		Gilles Piot, MD	Ph:  33-2-3274-3362
	Lille
	Centre Oscar Lambret
		Sylvia Giard-Lefevre, MD	Ph:  33-20-29-5945
			Email: s-giard@o-lambret.fr
	Limoges
	Centre Hospital Regional Universitaire de Limoges
		Nicole Tubiana-Mathieu, MD	Ph:  33-5-5505-6123
			Email: oncologie@chu-limoges.fr
	Mulhouse
	Centre Hospitalier de Mulhouse
		Magali Edel, MD	Ph:  33-03-8964-7521
	Nantes-Saint Herblain
	Centre Regional Rene Gauducheau
		Dominique Berton-Rigaud, MD	Ph:  33-2-40-479-959
	Perpignan
	Clinique Saint - Pierre
		Pierre Castera
	Reims
	Institut Jean Godinot
		Christiane Porrny	Ph:  33-03-2650-4444
	Rennes
	Centre Eugene Marquis
		Pierre Kerbrat, MD, PhD	Ph:  33-299-253-280
			Email: kerbrat@rennes.fnclcc.fr
	Rouen
	Centre Henri Becquerel
		Jean-Marie Ladonne	Ph:  33-2-3208-2222
	Toulouse
	Institut Claudius Regaud
		Laurence Gladieff, MD	Ph:  56-162-4119
			Email: gladieff@icr.fnclcc.fr
	Villejuif
	Institut Gustave Roussy
		Suzette Delaloge	Ph:  33-1-4211-5127
Switzerland
	Bern
	Inselspital Bern
		Manuela Rabaglio, MD	Ph:  41-31-632-4370
			Email: manuela.rabaglio@insel.ch
	Oncocare Sonnenhof-Klinik Engeriedspital
		Katharina Buser, MD	Ph:  41-31-309-9501
			Email: kbuser@sonnenhof.ch
	Geneva
	Hopital Cantonal Universitaire de Geneve
		Pierre Chappuis, MD	Ph:  41-22-372-9853
			Email: pierre.chappuis@hcuge.ch
	Lausanne
	Centre Hospitalier Universitaire Vaudois
		Contact Person	Ph:  41-21-314-0150
	Mendrisio
	Ospedale Beata Vergine
		Olivia Pagani, MD	Ph:  41-91-820-9111
	St. Gallen
	Tumor Zentrum ZeTup St. Gallen und Chur
		Senn Hans-Joerg, MD	Ph:  41-71-243-0043
			Email: hjsenn@sg.zetup.ch
	Thun
	Regionalspital
		Daniel Rauch, MD	Ph:  41-33-226-2645
United Kingdom
England
	Birmingham
	City Hospital - Birmingham
		Jenny Williamson	Ph:  44-012-1554-3801
	Bristol
	Frenchay Hospital
		Simon Cawthorn, FRCS	Ph:  44-117-970-1212
	Broomfield
	Broomfield Hospital
		Paul Sauven, MD, MS, FRCS	Ph:  44-1245-454-0761
			Email: paul.saauven@meht.nhs.uk
	Colchester
	Colchester General Hospital
		Fiona Macneill	Ph:  44-012-0674-7474
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Mark Lansdown	Ph:  44-113-206-6400
			Email: mark.lansdown@leedsth.nhs.uk
	Liverpool
	Royal Liverpool University Hospital
		Chris Holcombe	Ph:  44-151-706-2000
	London
	Cancer Research UK
		Jack Cuzick, PhD	Ph:  44-20-7269-3006
	St. Thomas' Hospital
		Hisham Hamed, FRCS, PhD, MBBCh	Ph:  44-207-188-4245 ext. 81467
			Email: hisham.hamed@cancer.org.uk
	Whittington Hospital
		Richard Sainsbury, MD	Ph:  44-20-7272-3070
	Manchester
	Christie Hospital
		Anthony Howell, MD	Ph:  44-161-446-8037
			Email: maria.parker@christie-tr.nwest.nhs.uk
	Newcastle-Upon-Tyne
	Newcastle Upon Tyne Hospitals NHS Trust
		Tom Lennard	Ph:  44-191-282-4661
			Email: t.w.j.lennard@ncl.ac.uk
	Nottingham
	Nottingham City Hospital NHS Trust
		John Robertson	Ph:  44-115-969-1169
	Southampton
	Royal South Hants Hospital
		Contact person	Ph:  44-23-8063-4288
Northern Ireland
	Belfast
	Centre for Cancer Research and Cell Biology at Queen's University Belfast
		Alan Wilkinson	Ph:  44-0-28-9026-3792
Scotland
	Dundee
	Ninewells Hospital
		Alistair M. Thompson	Ph:  44-1382-660-111
	Edinburgh
	Royal Infirmary of Edinburgh at Little France
		Elaine Anderson	Ph:  44-013-1536-1000
	Glasgow
	Western Infirmary
		W. George	Ph:  44-141-211-2166
Wales
	Cardiff
	University Hospital of Wales
		Robert Mansel	Ph:  44-292-0742-749
			Email: manselre@cf.ac.uk

Registry Information
Official Title		An International Multi-Centre Study Of Tamoxifen Vs Anastrozole In Postmenopausal Women With Ductal Carcinoma In Situ (DCIS)
Trial Start Date		2003-09-25
Registered in ClinicalTrials.gov		NCT00072462
Date Submitted to PDQ		2003-10-02
Information Last Verified		2007-07-03

Back to Top