NCT00090844终止2 期
Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 9
- 主要终点
- Time to Resumption of Menses
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy.
PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy.
Secondary
- Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug.
- Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug.
- Determine quality of life of patients treated with this drug.
- Determine disease-free and overall survival of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 44 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •Early-stage, operable disease
- •Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer
- •Hormone receptor status:
- •Meets 1 of the following criteria:
- •Estrogen receptor (ER)- OR progesterone receptor (PR)-positive
- •ER- AND PR-negative
- •No history of premature ovarian failure
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Premenopausal
- •Follicle-stimulating hormone levels < 40 IU/L at baseline AND at least 2 menstrual periods within the past 6 months
- •No first-degree relative menopausal at < 40 years of age
- •Performance status
- •Eastern Cooperative Oncology Group [ECOG] 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Fertile patients must use effective non-hormonal methods of contraception
- •No prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up
- •No known allergies to gonadotrophin-releasing hormone agonists
- •No other cancer except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No prior chemotherapy
- •Endocrine therapy
- •At least 2 weeks since prior oral contraceptives
- •No prior fertility treatment
- •Clomiphene or pergonal for polycystic ovarian disease allowed
- •No other concurrent oral or transdermal hormonal therapy, including any of the following:
- •Progesterone
- •Androgens
- •Aromatase inhibitors
- •Hormone replacement therapy
- •Oral contraceptives
- •Radiotherapy
- •No prior ovarian radiotherapy
- •No prior bilateral oophorectomy
- •No plans for oophorectomy or hysterectomy within the next 2 years
- •At least 1 week since prior warfarin
排除标准
- •History of premature ovarian failure
- •Over 45 years of age
- •First-degree relative menopausal at < 40 years of age
- •Pregnant or nursing
- •Prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up
- •Known allergies to gonadotrophin-releasing hormone agonists
- •Other cancer besides nonmelanoma skin cancer
- •Prior chemotherapy
- •Prior ovarian radiotherapy
- •Prior bilateral oophorectomy
研究组 & 干预措施
triptorelin
Experimental
GnRH analogue (triptorelin) during chemotherapy
干预措施: triptorelin (Drug)
结局指标
主要结局
Time to Resumption of Menses
时间窗: Baseline, end of chemotherapy then 5 years
Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years
次要结局
- Chemotherapy-related Amenorrhea(Baseline, end of chemotherapy then 5 years)
研究者
研究点 (9)
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