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

Alternate Title

Phase III Randomized Study of Continuous Letrozole Versus Intermittent Letrozole in Postmenopausal Women With Hormone Receptor-Positive, Node-Positive, Early-Stage Breast Cancer After Completion of 4 to 6 Years of Prior Adjuvant Endocrine Therapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Active Postmenopausal Other IBCSG-35-07 IBCSG-35-07, BIG-1-07-SOLE, EUDRACT-2007-001370-88, NCT00553410

Trial Description

Purpose:

Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.

This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor -positive, lymph node -positive, early-stage breast cancer.

Eligibility:

Eligibility criteria include the following:

• Has undergone previous surgery for breast cancer
• No inflammatory breast cancer
• Estrogen receptor-positive tumor or progesterone receptor-positive tumor
• No recurrent cancer or distant metastatic cancer
• No previous cancer in both breasts
• More than 1 year since hormone therapy
• 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 treatment groups.

Patients in group one will receive letrozole by mouth once a day for 5 years.

Patients in group two will receive letrozole by mouth once a day for 9 months in years 1-4, and for 12 months in year 5.

After finishing treatment, patients will be evaluated once a year.

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

International Breast Cancer Study Group

Melanie Schaerlig-Strausak, Study coordinator		Ph: 41-31-389-9391 Email: SOLE@ibcsg.org

Belgium
	Arlon
	Cliniques du Sud Luxembourg
		Contact Person	Ph:  32-63-23-1111
	Bonheiden
	Imelda vzw, Ziekenhuis
		Contact Person	Ph:  32-15-505-011
	Brasschaat
	AZ Klina
		Contact Person	Ph:  32-3-650- 5050
	Brussels
	Centre Hospitalier Universitaire Brugmann
		Contact Person	Ph:  32-2-477-21-11
	Cliniques Universitaires Saint-Luc
		Contact Person	Ph:  32-2-764-1111
	Institut Jules Bordet
		Contact Person	Ph:  32-2-541-3082
	Hasselt
	Virga Jesse Hospital
		Contact Person	Ph:  32-11-309-960
	Huy
	Centre Hospitalier Hutois
		Contact Person	Ph:  32-85-27-21-11
	Kortrijk
	AZ Groeninge - Oncologisch Centrum
		Contact Person	Ph:  32-56-234-305
	Leuven
	U.Z. Gasthuisberg
		Contact Person	Ph:  32-16-34-46-34
	Libramont
	Centre Hospitalier de l'Ardenne
		Contact Person	Ph:  32-61-238-790
	Liege
	CHU Liege - Domaine Universitaire du Sart Tilman
		Guy Jerusalem, MD, PhD	Ph:  32-43-667-111
			Email: g.jerusalem@chu.ulg.ac.be
	Clinique Saint-Joseph
		Contact Person	Ph:  32-4-224-8990
	Oostende
	AZ Damiaan
		Contact Person	Ph:  32-59-553-404
	Ottignies
	Clinique Saint-Pierre
		Contact Person	Ph:  32-10-437-211
	Rocourt
	Clinique Saint Vincent
		Contact Person	Ph:  32-4-239-4703
	Sint-Niklaas
	AZ Nikolaas - Sint-Niklaas
		Contact Person	Ph:  32-3-760-2985
	Verviers
	Centre Hospitalier Peltzer-La Tourelle
		Contact Person	Ph:  32-87-212-171
Hungary
	Budapest
	National Institute of Oncology
		Istvan Lang, MD, PhD, DSc	Ph:  36-1-224-8763
			Email: lang@oncol.hu
Italy
	Aviano
	Centro di Riferimento Oncologico - Aviano
		Contact Person	Ph:  39-43-465-9653
	Bolzano
	Azienda Sanitaria di Bolzano
		Contact Person	Ph:  39-471-908-572
	Milano
	European Institute of Oncology
		Marco Colleoni, MD	Ph:  39-02-5748-9934
Sweden
	Gothenburg
	Sahlgrenska University Hospital
		Per Karlsson, MD	Ph:  46-31-342-1000
Switzerland
	Aarau
	Kantonspital Aarau
		Contact Person	Ph:  41-62-838-6050
	Bern
	Inselspital Bern
		Stefan Aebi, MD	Ph:  41-31-632-4114
			Email: stefan.aebi@insel.ch
	International Breast Cancer Study Group
		Melanie Schaerlig-Strausak	Ph:  41-31-389-9391
	Freiburg
	Kantonsspital Freiburg
		Contact Person	Ph:  41-26-426-7111
	Mendrisio
	Ospedale Beata Vergine
		Olivia Pagani, MD	Ph:  41-91-811-3395
	St. Gallen
	Kantonsspital - St. Gallen
		Contact Person	Ph:  41-71-494-1062
	Tumor Zentrum ZeTup St. Gallen und Chur
		Contact Person	Ph:  41-71-243-0043
	Thun
	Regionalspital
		Contact Person	Ph:  41-33-226-2645
	Zurich
	Breast Center
		Contact Person	Ph:  41-44-380-7660

Registry Information
Official Title		SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women with Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer
Trial Start Date		2007-08-11
Trial Completion Date		2021-12-06 (estimated)
Registered in ClinicalTrials.gov		NCT00553410
Date Submitted to PDQ		2007-10-23
Information Last Verified		2008-09-04