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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00062400 |
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.
Condition | Intervention |
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Breast Cancer Cancer-Related Problem/Condition |
Procedure: psychosocial assessment and care |
Study Type: | Interventional |
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 |
Estimated Enrollment: | 385 |
Study Start Date: | May 2003 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | up to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed prior or current diagnosis of breast cancer
No evidence of infertility
Hormonal status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Investigator: | Angelo Di Leo, MD | Misericordia e Dolce Hospital |
Study ID Numbers: | CDR0000304757, EORTC-10002, BIG-3-98 |
Study First Received: | June 5, 2003 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00062400 |
Health Authority: | Unspecified |
sexual dysfunction and infertility sexuality and reproductive issues psychosocial effects/treatment stage I breast cancer stage II breast cancer |
Infertility Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |