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

Alternate Title

Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Educational/Counseling/Training Active 35 and under at diagnosis Other EORTC-10002 BIG-3-98, NCT00062400

Objectives

1. Determine the attitude toward the risk of infertility related to adjuvant therapy in women with early breast cancer.
2. Correlate, if possible, the patient's attitude with the fact that the patient already has children or the time interval between the date of breast cancer diagnosis and the date of study participation.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed prior or current diagnosis of breast cancer
  • Stage I or II
  • No relapsed disease



• No evidence of infertility
  • Regular menses or regular hormonal contraception use for the past 3 months



• Hormonal status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 35 and under at diagnosis

Sex

• Female

Menopausal status

• Premenopausal

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No psychological, familial, sociological, or geographical condition that would preclude study compliance

Expected Enrollment

A total of 385 patients will be accrued for this study.

Outcomes

Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire

Outline

This is a multicenter study.

Patients complete a questionnaire administered by a nontreating physician.

Neskovic-Konstantinovic Z, Gomez H, Senkus-Konefka E, et al.: A Breast International Group survey of young breast cancer patients attitudes towards the risk of loss of fertility related to adjuvant therapies: EORTC protocol 10002 — BIG 3-98. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-3106, 2008.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Angelo Di Leo, MD, Study coordinator		Ph: 39-0574-43-4766 Email: adileo@usl4.toscana.it

Belgium
	Brussels
	Centre Hospitalier Etterbeek Ixelles
		Contact Person	Ph:  32-641-4111
	Institut Jules Bordet
		Contact Person	Ph:  32-2-541-3181
	Liege
	CHU Liege - Domaine Universitaire du Sart Tilman
		Contact Person	Ph:  32-4-366-7111
	Wilrijk
	Algemeen Ziekenhuis Sint-Augustinus
		Contact Person	Ph:  32-3-443-37-37
Chile
	Santiago
	Clinica Alemana
		Contact Person
	Hospital Militar
		Contact Person
	Instituto de Radiomedicina
		Contact Person	Ph:  56-2-754-1700
Croatia
	Zagreb
	University Hospital Rebro
		Contact Person	Ph:  385-1-238-8644
Germany
	Frankfurt
	Klinikum der J.W. Goethe Universitaet
		Contact Person	Ph:  49-69-6301-5744
	Heidelberg
	Universitatsklinikum Heidelberg
		Contact Person	Ph:  49-6221-56-7029
Italy
	Aviano
	Centro di Riferimento Oncologico - Aviano
		Contact Person	Ph:  39-0434-659-111
	Cremona
	Azienda Istituti Ospitalieri
		Contact Person	Ph:  372-405111
	Lecco
	Ospedale Alessandro Manzoni
		Contact Person
	Milan
	European Institute of Oncology
		Contact Person	Ph:  39-02-5748-9861
Lebanon
	Beirut
	American University of Beirut Medical Center
		Contact Person	Ph:  961-1-350-000
Netherlands
	Amsterdam
	Academisch Medisch Centrum at University of Amsterdam
		Contact Person	Ph:  31-20-566-9111
	Arnhem
	Arnhems Radiotherapeutisch Instituut
		Contact Person	Ph:  31-26-371-2412
Peru
	Lima
	Instituto Nacional de Enfermedades Neoplasicas
		Contact Person	Ph:  51-1-612-9700
Poland
	Gdansk
	Medical University of Gdansk
		Contact Person	Ph:  48-58-349-2000
Portugal
	Lisboa
	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
		Contact Person	Ph:  351-21-722-9800
Republic of South Africa
	Cape Town
	Groote Schuur Hospital
		Contact Person	Ph:  27-21-404-4265
Serbia
	Belgrade
	Institute of Oncology and Radiology of Serbia
		Contact Person	Ph:  381-361-4660
Switzerland
	Bern
	Inselspital Bern
		Contact Person	Ph:  41-31-632-2243
	Mendrisio
	Ospedale Beata Vergine
		Contact Person	Ph:  41-91-646-0101
	St. Gallen
	Kantonsspital - St. Gallen
		Contact Person	Ph:  41-71-494-1062
Turkey
	Istanbul
	Marmara University Hospital
		Contact Person	Ph:  90-327-5050
United Kingdom
Scotland
	Glasgow
	Western Infirmary
		Contact Person	Ph:  44-141-211-2000

Registry Information
Official Title		A Survey of the Breast International Group (B.I.G.) to Assess the Attitude of Patients Aged Less Than 35 Years, with Early Breast Cancer, Toward the Risk of Loss of Fertility Related to Adjuvant Therapies
Trial Start Date		2003-05-05
Trial Completion Date		2008-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00062400
Date Submitted to PDQ		2003-05-07
Information Last Verified		2008-04-13

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