Study of Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Compare the potential benefits of adjuvant toremifene with or without goserelin in premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied with or without chemotherapy induced amenorrhoea.
详细描述
This is a single center, randomized, controlled study. Patients undergo surgical resection with standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T).
Chemotherapy begins within 4 weeks after surgery for patients randomized to arm I-IV. Arm I: patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Arm II: patients who had CIA receive toremifene as in arm I. Arm III: patients without CIA receive oral toremifene and goserelin for ovarian function suppression. Arm IV: patients with CIA receive oral toremifene and goserelin for ovarian function suppression. Patients are followed every 6 months for 5 years and annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age of at least 18 and at most 45 years
- •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) positive 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 underwent standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T)
- •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
研究组 & 干预措施
Arm I
Patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity
干预措施: Toremifene (Drug)
Arm II
Patients who had CIA receive toremifene as in arm I
干预措施: Toremifene (Drug)
Arm III
Patients without CIA receive oral toremifene and goserelin for ovarian function suppression
干预措施: Goserelin (Drug)
Arm IV
Patients with CIA receive oral toremifene and goserelin for ovarian function suppression.
干预措施: Goserelin (Drug)
结局指标
主要结局
Disease free survival
时间窗: up to 120 months
Overall Survival
时间窗: up to 120 months
次要结局
- Quality of life(up to 120 months)
- Bone mineral density loss(up to 120 months)
- Hormone levels(up to 120 months)
- Incidence of pregnancy(up to 120 months)
研究者
ZHOU Yidong
Professor
Peking Union Medical College Hospital