- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00062400
Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer
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
RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause infertility. Assessing young women's attitudes and feelings about the risk of infertility may help improve the ability to plan effective treatment.
PURPOSE: This clinical trial is studying young women's attitudes and feelings about the risk of infertility related to adjuvant therapy for stage I or stage II breast cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the attitude toward the risk of infertility related to adjuvant therapy in women with early breast cancer.
- 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.
OUTLINE: This is a multicenter study.
Patients complete a questionnaire administered by a nontreating physician.
PROJECTED ACCRUAL: A total of 385 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Brussels, Belgium, B-1050
- Centre Hospitalier Etterbeek Ixelles
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Liege, Belgium, B-4000
- CHU Liege - Domaine Universitaire du Sart Tilman
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Wilrijk, Belgium, 2610
- Algemeen Ziekenhuis Sint-Augustinus
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Santiago, Chile, 10
- Instituto de Radiomedicina
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Santiago, Chile, 5951
- Clínica Alemana
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Santiago, Chile
- Hospital Militar
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Zagreb, Croatia, 41000
- University Hospital Rebro
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Frankfurt, Germany, D-60590
- Klinikum der J.W. Goethe Universitaet
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Heidelberg, Germany, 69115
- Universitätsklinikum Heidelberg
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Aviano, Italy, 33081
- Centro di Riferimento Oncologico - Aviano
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Cremona, Italy, 26100
- Azienda Istituti Ospitalieri
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Lecco, Italy, 23900
- Ospedale Alessandro Manzoni
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Milan, Italy, 20141
- European Institute of Oncology
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Beirut, Lebanon, 113-6044
- American University of Beirut Medical Center
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Amsterdam, Netherlands, 1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Arnhem, Netherlands, 6815 AD
- Arnhems Radiotherapeutisch Instituut
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Lima, Peru, 34
- Instituto Nacional de Enfermedades Neoplasicas
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Gdansk, Poland, 80-211
- Medical University of Gdansk
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Lisboa, Portugal, 1099-023 Codex
- Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
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Belgrade, Serbia, 11000
- Institute of Oncology and Radiology of Serbia
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Cape Town, South Africa, 7925
- Groote Schuur Hospital
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Bern, Switzerland, CH-3010
- Inselspital Bern
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Mendrisio, Switzerland, CH-6850
- Ospedale Beata Vergine
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St. Gallen, Switzerland, CH-9007
- Kantonsspital - St. Gallen
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Istanbul, Turkey, 81190
- Marmara University Hospital
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Scotland
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Glasgow, Scotland, United Kingdom, G11 6NT
- Western Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- Not specified
Surgery
- Not specified
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
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Collaborators and Investigators
Investigators
- Study Chair: Zora Neskovic-Konstantinovic, Institute Of Oncology & Radiology, Belgrade, Serbia
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-10002
- BIG-3-98
- IBCSG-29-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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