Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen for Hormone Receptor-Positive Breast Cancer in Women Younger Than 35: A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 680
- 试验地点
- 24
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
The objective of this study is to compare the curative effects in patients under the age of 35 with hormone receptor positive breast cancer and high recurrent risk factors including large tumor or metastatic lymph nodes randomized to ovarian function suppression (OFS) plus aromatase inhibitors or OFS plus tamoxifen as adjuvant endocrine therapy, and explore the differences of curative effects between different subtypes to provide direct evidence for treatments of young breast cancer patients.
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
- None
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- •Patients pathologically diagnosed with hormone receptor positive invasive breast cancer: immunohistochemistry ER positive (≥1%);
- •Premenopausal patients with age ≤35 years (at least menstruate once for prior 3 months, assess menstruation situation before chemotherapy if have);
- •No distant metastasis;
- •Clinical stage (TNM) meets at least one of the conditions as follow: T≥2cm or at least one region of regional lymph node metastasis (including micrometastases);
- •Patients must have undergone a surgery and (neo)adjuvant chemotherapy, targeted therapy, radiotherapy (if necessary) according to Chinese Anti-Cancer Association guidelines and specifications version 2015 for diagnosis and treatment of breast cancer;
- •Indexes of hematology and biochemistry conform to following standards: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2xULN, TBIL, DBIL, CCr≤1.5xULN.
排除标准
- •Pregnant or lactating women or women of childbearing potential reject contraceptive measures;
- •History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
- •Concurrent malignancies or history of non-breast malignancies within the 5 years prior to study entry, except for curatively treated basal cell and squamous cell carcinomas of the skin, carcinoma in situ of the cervix; peripheral nervous system disorders caused by diseases or history of obvious mental and central nervous system disorders;
- •Prior use of neo-adjuvant chemotherapy after a definite diagnosis;
- •Nervous system disorders caused by diseases or obvious mental disorder, which would affect patients right to consent and compliance, or make patients in critical condition;
- •Serious hepatopathy (e.g., cirrhosis, etc.), nephropathy, respiratory illness, digestive illness or poorly controlled diabetes;
- •Cardiac illness with obvious abnormal EKG or clinical symptoms, namely congestive heart failure, coronary atherosclerotic heart disease with obvious symptoms, arrhythmia difficult to control by drugs, or history of myocardial infarction within the 12 months prior to study entry or class III/IV of cardiac function;
- •Concurrent treatment in another investigational trial;
- •Sensitivity or contraindication to any of the study medications.
研究组 & 干预措施
Ovarian Suppression and aromatase inhibitors
Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.
AI: no restriction of specific drugs, oral by standard dose of post-menopause breast cancer, for 5 years.
干预措施: Goserelin (Drug)
Ovarian Suppression and aromatase inhibitors
Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.
AI: no restriction of specific drugs, oral by standard dose of post-menopause breast cancer, for 5 years.
干预措施: Aromatase Inhibitors (Drug)
Ovarian Suppression and aromatase inhibitors
Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.
AI: no restriction of specific drugs, oral by standard dose of post-menopause breast cancer, for 5 years.
干预措施: Leuprolide (Drug)
Ovarian Suppression and tamoxifen
Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.
Tamoxifen: 20mg oral for every day, for 5 years.
干预措施: Goserelin (Drug)
Ovarian Suppression and tamoxifen
Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.
Tamoxifen: 20mg oral for every day, for 5 years.
干预措施: Tamoxifen (Drug)
Ovarian Suppression and tamoxifen
Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.
Tamoxifen: 20mg oral for every day, for 5 years.
干预措施: Leuprolide (Drug)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: 5 years
DFS is defined as the time between randomization and the date of the first occurrence of events as follow: local, regional recurrence or distant metastasis of invasive breast cancer, contralateral invasive breast cancer, or death due to any diseases. Patients who have not had disease progression or death at the end of follow-up (5 years) will be censored at the date last known to be alive and distant metastasis free. Subgroup analysis DFS of Luminal A and Luminal B breast cancer.
次要结局
- Overall Survival (OS)(5 years)
- Invasive Breast Cancer Recurrence-Free Interval（BCFI)(5 years)
- Adverse Effects Rate(5 years)
研究者
Ying Lin
Vice Director of Department of Breast Surgery
First Affiliated Hospital, Sun Yat-Sen University