NCT00062400CompletedNot Applicable
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
European Organisation for Research and Treatment of Cancer - EORTC53 sites in 15 countries385 target enrollmentStarted: May 1, 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 385
- Locations
- 53
- Primary Endpoint
- Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Primary Purpose
- Other
Eligibility Criteria
- Ages
- 0 Years to 35 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion 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
- •PATIENT CHARACTERISTICS:
- •35 and under at diagnosis
- •Menopausal status
- •Premenopausal
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •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
- •Not specified
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (53)
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