Breast Cancer Clinical Trial
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
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.
Status | Completed |
Enrollment | 385 |
Est. completion date | |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 35 Years |
Eligibility |
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 |
N/A
Country | Name | City | State |
---|---|---|---|
Belgium | Centre Hospitalier Etterbeek Ixelles | Brussels | |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | CHU Liege - Domaine Universitaire du Sart Tilman | Liege | |
Belgium | Algemeen Ziekenhuis Sint-Augustinus | Wilrijk | |
Chile | Clinica Alemana | Santiago | |
Chile | Hospital Militar | Santiago | |
Chile | Instituto de Radiomedicina | Santiago | |
Croatia | University Hospital Rebro | Zagreb | |
Germany | Klinikum der J.W. Goethe Universitaet | Frankfurt | |
Germany | Universitatsklinikum Heidelberg | Heidelberg | |
Italy | Centro di Riferimento Oncologico - Aviano | Aviano | |
Italy | Azienda Istituti Ospitalieri | Cremona | |
Italy | Ospedale Alessandro Manzoni | Lecco | |
Italy | European Institute of Oncology | Milan | |
Lebanon | American University of Beirut Medical Center | Beirut | |
Netherlands | Academisch Medisch Centrum at University of Amsterdam | Amsterdam | |
Netherlands | Arnhems Radiotherapeutisch Instituut | Arnhem | |
Peru | Instituto Nacional de Enfermedades Neoplasicas | Lima | |
Poland | Medical University of Gdansk | Gdansk | |
Portugal | Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA | Lisboa | |
Serbia | Institute of Oncology and Radiology of Serbia | Belgrade | |
South Africa | Groote Schuur Hospital | Cape Town | |
Switzerland | Inselspital Bern | Bern | |
Switzerland | Ospedale Beata Vergine | Mendrisio | |
Switzerland | Kantonsspital - St. Gallen | St. Gallen | |
Turkey | Marmara University Hospital | Istanbul | |
United Kingdom | Western Infirmary | Glasgow | Scotland |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC | German Adjuvant Breast Cancer Group, International Breast Cancer Study Group |
Belgium, Chile, Croatia, Germany, Italy, Lebanon, Netherlands, Peru, Poland, Portugal, Serbia, South Africa, Switzerland, Turkey, United Kingdom,
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] 31
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire | No |
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