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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 Letrozole in Preventing Breast Cancer in Postmenopausal Women With the BRCA1/BRCA2 Mutation

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Biomarker/Laboratory analysis, Prevention Active 40 to 69 Other, Pharmaceutical / Industry FNCLCC-ONCO-03/0701 FNCLCC-ONCO 03/0701 - LIBER, EU-20806, NOVARTIS-FNCLCC-ONCO 03/0701, NCT00673335

Trial Description

Purpose:

Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.

This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.

Eligibility:

Eligibility criteria include the following:

• 40-69 years old
• No recurrent breast cancer
• No previous cancer in both breasts
• No previous surgery to remove tumors in both breasts
• At least 3 months since hormone replacement therapy
• 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 (have an equal chance of being placed) to one of two treatment groups.

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

Patients in group two will receive a placebo by mouth once a day.

Treatment in both groups may continue for up to 5 years.

Patients will undergo blood sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated 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

Federation Nationale des Centres de Lutte Contre le Cancer

Pascal Pujol, MD, Study coordinator		Ph: 33-467-335-875

France
	Avignon
	Institut Sainte Catherine
		Contact Person	Ph:  33-490-27-61-61
	Caen
	Centre Regional Francois Baclesse
		Contact Person	Ph:  33-2-3145-5000
	Clermont-Ferrand
	Centre Jean Perrin
		Contact Person	Ph:  33-73-278-080
	Lille
	Centre Oscar Lambret
		Contact Person	Ph:  33-32-029-5959
	Lyon
	Centre Leon Berard
		Contact Person	Ph:  33-4-78-78-26-45
	Marseille
	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
		Contact Person	Ph:  33-4-9122-3700
	Montpellier
	Hopital Arnaud de Villeneuve
		Contact Person	Ph:  33-467-335-875
	Nantes
	Centre Catherine de Sienne
		Contact Person	Ph:  33-40-02-28-272-000
	Nice
	Centre Antoine Lacassagne
		Contact Person	Ph:  33-49-203-1000
	Niort
	Centre Hospitalier General de Niort
		Contact Person	Ph:  33-5-4932-7979
	Paris
	Hopital Saint Michel
		Contact Person	Ph:  33-1-4045-6363
	Hotel Dieu de Paris
		Contact Person	Ph:  33-1-42-348-413
	Institut Curie Hopital
		Contact Person	Ph:  33-44-32-4000
	Poitiers
	CHU Poitiers
		Contact Person	Ph:  33-549-444-538
	Reims
	Polyclinique De Courlancy
		Contact Person	Ph:  33-3-2677-2777
	Rennes
	Centre Eugene Marquis
		Contact Person	Ph:  33-2-9925-3000
	Rouen
	Centre Henri Becquerel
		Contact Person	Ph:  33-2-3208-2222
	Saint Cloud
	Centre Rene Huguenin
		Contact Person	Ph:  33-1-47-111-515
	Sainte-Etienne
	CHU Sainte-Etienne - Hopital Nord
		Contact Person	Ph:  33-4-77-82-80-00
	Strasbourg
	Centre Paul Strauss
		Contact Person	Ph:  33-3-8825-2424
	Toulouse
	Institut Claudius Regaud
		Contact Person	Ph:  33-5-6142-4242
	Vandoeuvre-les-Nancy
	Centre Alexis Vautrin
		Contact Person	Ph:  33-3-8359-8400
	Villejuif
	Institut Gustave Roussy
		Contact Person	Ph:  33-1-4211-4339

Registry Information
Official Title		Prevention of breast cancer by letrozole in post-menopausal women carrying a BRCA ½ mutation
Trial Start Date		2008-05-27
Trial Completion Date		2015-02-15 (estimated)
Registered in ClinicalTrials.gov		NCT00673335
Date Submitted to PDQ		2008-02-07
Information Last Verified		2008-08-27