NCT00196846已完成2 期
Prospective Randomized Multicenter Study to Prevent Chemotherapy Induced Ovarian Failure With the GnRH-Agonist Goserelin in Young Hormone Insensitive Breast Cancer Patients Receiving Anthracycline Containing (Neo-)Adjuvant Chemotherapy
German Breast Group2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2005年3月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Normal ovarian function as defined by two consecutive menstrual periods within 21-35 days within a time frame of 5 - 8 months after last application of goserelin
研究概览
简要总结
Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure
详细描述
Study Design:
Prospective, randomized, open phase II trial
Schedule:
All patients will receive an anthracycline-containing polychemotherapy.
Patients randomized to Goserelin will receive their first injection of 3.6 mg at least 2 weeks before start of chemotherapy. Goserelin will be given as a subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) until the end of the last chemotherapy cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures
- •Complete baseline documentation sent to GBG
- •Age of at least 18 and at most 45 years
- •Patients request to preserve ovarian function
- •Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase
- •Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy
- •Steroid receptor (estrogen and progesterone) negative tumor (diagnosis according to hospital standard-procedures)
- •No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated
- •Karnofsky-Index >80%
- •Life expectancy of at least 10 years, disregarding the diagnosis of cancer
- •Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution
- •Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.
排除标准
- •Known hypersensitivity reaction to the investigational compounds or incorporated substances
- •Prior cytotoxic treatment for any reason
- •Suspected (primary or secondary) ovarian insufficiency
- •Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment; prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
- •Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
- •Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
- •Concurrent treatment with other experimental drugs or any other anti-cancer therapy
- •Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry
结局指标
主要结局
Normal ovarian function as defined by two consecutive menstrual periods within 21-35 days within a time frame of 5 - 8 months after last application of goserelin
时间窗: December 2008
次要结局
- Discontinuation or delay of Goserelin injections(December 2008)
- Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin(December 2008)
- Discontinuation, delay, or dose-reductions of chemotherapy(December 2008)
- Evaluation according to EORTC Q 30(March 2010)
- According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months(March 2010)
- Date of first regular menstrual period(March 2010)
- Any diagnosis of pregnancy during study follow up(March 2010)
研究者
研究点 (2)
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