NCT00427245已完成3 期
Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]
Anglo Celtic Cooperative Oncology Group131 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2004年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 131
- 主要终点
- Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
研究概览
简要总结
RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare menopausal symptoms in patients treated with these regimens.
- Compare bone mineral density loss in patients treated with these regimens.
- Compare hormone levels in patients treated with these regimens.
- Compare menstruation in patients treated with these regimens.
- Compare the incidence of pregnancy in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive breast cancer
- •Stages I-IIIB with node-positive or -negative disease (N0-2)
- •Operable disease
- •Must meet 1 of the following criteria:
- •Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks
- •Scheduled to receive neoadjuvant chemotherapy
- •No metastatic breast cancer, including supraclavicular fossa metastases
- •Hormone receptor status meeting 1 of the following criteria:
- •Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy
- •ER positive AND no requirement for ovarian suppression as a necessary part of treatment
- •PATIENT CHARACTERISTICS:
- •Premenopausal with regular menses in the 12 months preceding surgery
- •No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •Suitable fitness status for chemotherapy
- •Adequate hepatic, renal, and bone marrow function
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior chemotherapy or endocrine therapy
排除标准
- 未提供
结局指标
主要结局
Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
次要结局
- Incidence of menopausal symptoms
- Quality of life
- Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
- Incidence of pregnancy
- Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin, and estradiol) as measured after course 3, after course 6 or 8 (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to 5 years
- Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
研究者
研究点 (131)
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