NCT00062400已完成不适用
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 个研究点 分布在 15 个国家目标入组 385 人开始时间: 2003年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 53
- 主要终点
- Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Other
入排标准
- 年龄范围
- 0 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
次要结局
未报告次要终点
研究者
研究点 (53)
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