Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Adjuvant Tamoxifen Compared With Anastrozole in Treating 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

Objectives

Primary

1. 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.
2. Compare side effect profiles of these drugs in these patients.

Secondary

1. Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients.
2. Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients.
3. Compare breast cancer mortality in patients treated with these drugs.
4. Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients.
5. Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs.

Entry 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
    • Greater than 5% positive cells

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No prior or concurrent tamoxifen use lasting more than 3 months unless treatment was completed more than 5 years ago
• No prior or concurrent raloxifene use lasting more than 3 months unless treatment was completed more than 5 years ago
• No other prior or concurrent selective estrogen-receptor modulator use lasting more than 3 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

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

Expected Enrollment

A total of 4,000 patients will be accrued for this study within 4 years.

Outcomes

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

Breast cancer mortality with median follow-up at 10 years

Outline

This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. 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.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

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	Ph:  41-33-226-2626
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