Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- Distant recurrence-free survival
研究概览
简要总结
Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).
In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.
详细描述
- Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).
- In these, ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.
- Either goserelin acetate or leuprorelin Acetate is allowed.
- These patients are able to choose bilateral salpingo-oophorectomy instead of OFS.
- Chemotherapy is omitted in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ER+HER2- breast cancer
- •Premenopausal and age <=50
- •N1 including micrometastasis
- •Genomic Low Risk by OncoFREE test® (1-20)
排除标准
- •Postmenopausal women
- •ER-negative breast cancer
研究组 & 干预措施
OFS with endocrine
Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, the patients with a genomic low risk using the multigene-assay (OncoFREE®) will be included in this arm.
干预措施: Ovarian function suppression with endocrine treatments (Drug)
结局指标
主要结局
Distant recurrence-free survival
时间窗: 5-years distant recurrence-free survival
The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause
次要结局
- Recurrence-free survival (RFS)(5-years RFS)
- Invasive disease-free survival (iDFS)(5-years iDFS)
研究者
Sung Gwe Ahn
Associated Professor
Gangnam Severance Hospital