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Clinical Trial Questions?
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Study of Attitudes Toward the Risk of Infertility Related to Adjuvant Therapy in Women With Early Breast Cancer
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 | Protocol IDs |
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| No phase specified | Educational/Counseling/Training | Active | 35 and under at diagnosis | EORTC-10002
BIG-3-98, NCT00062400 |
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.
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:
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy - See Disease Characteristics
Radiotherapy Surgery Patient Characteristics:
Age - 35 and under at diagnosis
Sex Menopausal status Performance status Life expectancy Hematopoietic Hepatic Renal Other - No psychological, familial, sociological, or geographical condition that would preclude study compliance
Expected Enrollment 385A total of 385 patients will be accrued for this study. Outcomes Primary Outcome(s)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. Published ResultsNeskovic-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 | | | |
Trial Sites
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| Belgium |
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Brussels |
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| | | | Centre Hospitalier Etterbeek Ixelles |
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| | | Institut Jules Bordet |
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Liege |
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| | | CHU Liege - Domaine Universitaire du Sart Tilman |
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Wilrijk |
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| | | Algemeen Ziekenhuis Sint-Augustinus |
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| Chile |
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Santiago |
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| | | | Clinica Alemana |
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| | | Hospital Militar |
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| | | Instituto de Radiomedicina |
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| Croatia |
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Zagreb |
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| | | | University Hospital Rebro |
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| Germany |
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Frankfurt |
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| | | | Klinikum der J.W. Goethe Universitaet |
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Heidelberg |
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| | | Universitatsklinikum Heidelberg |
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| Italy |
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Aviano |
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| | | | Centro di Riferimento Oncologico - Aviano |
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Cremona |
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| | | Azienda Istituti Ospitalieri |
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Lecco |
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| | | Ospedale Alessandro Manzoni |
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Milan |
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| | | European Institute of Oncology |
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| Lebanon |
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Beirut |
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| | | | American University of Beirut Medical Center |
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| Netherlands |
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Amsterdam |
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| | | | Academisch Medisch Centrum at University of Amsterdam |
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Arnhem |
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| | | Arnhems Radiotherapeutisch Instituut |
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| Peru |
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Lima |
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| | | | Instituto Nacional de Enfermedades Neoplasicas |
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| Poland |
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Gdansk |
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| | | | Medical University of Gdansk |
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| Portugal |
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Lisboa |
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| | | | Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA |
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| Republic of South Africa |
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Cape Town |
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| | | | Groote Schuur Hospital |
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| Serbia |
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Belgrade |
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| | | | Institute of Oncology and Radiology of Serbia |
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| Switzerland |
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Bern |
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| | | | Inselspital Bern |
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Mendrisio |
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| | | Ospedale Beata Vergine |
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St. Gallen |
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| | | Kantonsspital - St. Gallen |
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| Turkey |
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Istanbul |
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| | | | Marmara University Hospital |
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| United Kingdom |
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| Scotland |
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Glasgow |
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| | | | | Western Infirmary |
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| 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 | | 2009-06-14 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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