Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR)
Local Treatment in Addition to Endocrine Therapy in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR): a Multicentre, Single -Arm, Phase 2 Trial
研究概览
地位
详细说明
Local treatment included surgical resection, stereotactic body radiotherapy, palliative radiotherapy, and radiofrequency ablation. Stereotactic body radiotherapy is preferred as a radiation modality.
Endocrine therapies with/without target therapy including CDK4/6 inhibitors or mTOR inhibitors are the mainstay of 1st line treatment for ER-positive/HER2-negative metastatic breast cancer.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Sung Gwe Ahn, Ph.D.
- 电话号码：82-2-2019-4402
- 邮箱：asg2004@yuhs.ac
研究联系人备份
- 姓名：Joon Jeong, Ph.D.
- 电话号码：82-2-2019-3379
- 邮箱：gsjjoon@yuhs.ac
学习地点
-
-
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Seoul、大韩民国、135720
- 招聘中
- Gangnam Severance Hospital
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接触：
- Joon Jeong, M.D.,Ph.D.
- 电话号码：82220193370
- 邮箱：gsjjoon@yuhs.ac
-
接触：
- Sung Gwe Ahn, M.D.
- 电话号码：82220193370
- 邮箱：asg2004@yuhs.ac
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-ER-positive/HER2-negative in primary tumor
- Oligometastases: ≤ 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant LNs)
- Recurrent cancer after completion of primary treatment (RFI≥1year)
- Metastatic lesions are feasible for resection or radiotherapy (Size≤3cm)
Exclusion Criteria:
- De Novo metastatic cancer at initial diganosis
- Recurrence-free inverval < 1 year
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Endocrine and local treatments
Endocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer. Endocrine options included aromatase inhibitors, aromatase inhibitors with CDK4/6 inhibitors, fulvestrant, fulvestrant with CDK4/6 inhibitors, everolimus with exemestane, tamoxifen. For premenopausal women, agents for ovarian function suppression using GnRH agonists or surgical ovarian ablation including bilateral salpingo-oophorectomy are allowed. Local treatments for metastatic lesions will be added in this group. Local treatments include modalities described below: i) Surgical resection: the achievement of tumor-free margin is not obligatory. ii) Stereotactic body radiotherapy iii) Radiofrequency ablation |
Surgical resection for their metastatic lesions will be performed.
Achievement of tumor-free margin is not mandatory.
Deliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues.
Total radiation dose and fractions are various according to metastatic lesions (57~97.5Gy/6~10
Fraction).
其他名称：
RFA is a localized thermal treatment technique designed to induce tumor destruction by heating the tumor tissue to temperatures that exceed 60℃.
The alternating current of radiofrequency waves passing down from an uninsulated electrode tip into the surrounding tissues generates changes in the direction of ions and creates ionic agitation and frictional heating.
This tissue heating then drives extracellular and intracellular water out of the tissue, resulting in tissue destruction by coagulative necrosis.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-free survival
大体时间：From the date of registration to the date of first PFS failure or last follow-up; assessed up to 6 years; Median PFS of all registered patients will be over 30 months
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Failure: progression or death due to any cause
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From the date of registration to the date of first PFS failure or last follow-up; assessed up to 6 years; Median PFS of all registered patients will be over 30 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall survival
大体时间：From the date of registration to the date of death or last follow-up; assessed up to 10 years
|
Failure: death due to any cause
|
From the date of registration to the date of death or last follow-up; assessed up to 10 years
|
合作者和调查者
调查人员
- 首席研究员：Joon Jeong, Ph.D.、Gangnam Severance Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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