Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapy (CS)
2022年7月17日 更新者:Yue Yu、Changhai Hospital
Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapywhich Patients Will Benefit From Surgery
For patients with de novo stage IV breast cancer, the current debate is whether local surgery can improve the survival of patients.
There is no clinical study on the classification after systemic treatment of de novo stage IV breast cancer patients.
In fact, the clinical stage of tumor can change with the change of treatment.
For example, the stage Ⅲ of locally advanced breast cancer can down-staging to the stage Ⅱ after systemic treatment.
Similarly, patients with stage Ⅳ can down-staging to stage Ⅱ or stage Ⅲ after systemic treatment.
At this time, the patient can receive surgical treatment.
Therefore, this study is to first treat de novo stage IV breast cancer patients with systemic treatment, according to the response after systemic treatment to give different treatment measures(surgery or continued systemic treatment).
The investigators hope that this study will provide new ideas for the treatment of de novo stage IV breast cancer and other de novo stage IV cancers.
研究概览
地位
尚未招聘
详细说明
This study analysed and summarized the outcomes of the primary and metastatic lesions after first-line systemic therapy in patients with newly diagnosed breast cancer and then inferred the timing of surgical treatment.
According to the tumour heterogeneity characteristics between the primary and metastatic tumours, the investigators investigated the following A, B and C scenarios.
After systemic therapy in patients with de novo metastatic breast cancer, the outcomes of primary and metastatic lesions were mainly divided into four categories (Fig. 1a, b, c, d).
It is worth noting that after treatment, the four conditions of a, b, c, and d may alternate with the progression of the tumour or modification of the treatment plan.
Therefore, only a proactive evaluation and timely treatment can identify the time window for tumour treatment.
The time window for surgical treatment is important because, once missed, the tumour may progress with new metastatic lesions.
Figure 1-a: Imaging study indicates complete remission of primary and metastatic tumours.
Diagnostic surgical treatment can be performed to determine whether a pathologic complete response (PCR) is achieved and to develop a subsequent treatment plan.
Figure 1-b: Imaging study indicates complete remission of the metastatic tumour with residual primary tumour.
The state of the patient in this scenario could be equivalent to that of patients with early resectable breast cancer.
Surgical treatment of the primary tumour should be promptly performed.
Figure 1-c: Complete remission of the primary and residual metastatic tumour.
Surgical treatment can be selected for isolated and resectable metastatic tumour.
Figure 1-d: No remission or even progression of the primary and metastatic tumours.
The systemic treatment plan should be replaced, and the surgical treatment should not be considered.
研究类型
介入性
注册 (预期的)
362
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:YU YUE, doctor
- 电话号码:+86 13564261349
- 邮箱:dr-array@hotmail.com
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Study Population Operable stage IV breast cancer patients, whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imaginology examination
Inclusion Criteria:
- Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.
- ECOG-PS 0-2.
- Bone marrow, liver and kidney should be fully functional.
- Patients didn't received the locoregional surgery of the primary tumor in de novo.
- For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.
Exclusion Criteria:
- Accompanied with other primary malignant tumors.
- More than two visceral organ involvement.
- Patients who can't plan for follow-up effectively and regularly.
- Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:顺序分配
- 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:1 Primary and metastatic lesions PCR
surgery 1 Mastectomy OR Breast conserving surgery
|
Mastectomy OR Breast conserving surgery
其他名称:
|
|
实验性的:2 Primary lesions NPCR and metastatic lesions PCR
surgery 1 Mastectomy OR Breast conserving surgery
|
Mastectomy OR Breast conserving surgery
其他名称:
|
|
实验性的:3 Primary lesions PCR and metastatic lesions NPCR
surgery 2 Resection of metastasis
|
Resection of metastasis
其他名称:
|
|
实验性的:4 Primary lesions NPCR and metastatic lesions NPCR
Systemic therapy Endocrine therapy or chemotherapy or targeted therapy
|
Endocrine therapy or chemotherapy or targeted therapy
|
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 |
|---|---|---|
|
Overall survival
大体时间:5 years
|
Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
|
5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
局部无进展生存期
大体时间:5年
|
定义为诊断时间与局部区域复发或死亡发生时间之间的时间。
|
5年
|
|
远期无进展生存期
大体时间:5年
|
Distant disease free survival (D-DFS),定义为从新诊断IV期乳腺癌到确认远处进展或因任何其他原因死亡的时间。
|
5年
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:YU YUE, doctor、Department of thyroid and breast surgery, Changhai Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年8月1日
初级完成 (预期的)
2030年12月31日
研究完成 (预期的)
2031年5月1日
研究注册日期
首次提交
2022年3月9日
首先提交符合 QC 标准的
2022年3月16日
首次发布 (实际的)
2022年3月17日
研究记录更新
最后更新发布 (实际的)
2022年7月19日
上次提交的符合 QC 标准的更新
2022年7月17日
最后验证
2022年7月1日
更多信息
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