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临床试验/NCT05285332
NCT05285332尚未招募不适用

Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapywhich Patients Will Benefit From Surgery

Changhai Hospital0 个研究点目标入组 362 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
362
主要终点
Overall survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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-
  • 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.

排除标准

  • 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).

研究组 & 干预措施

1 Primary and metastatic lesions PCR

Experimental

surgery 1 Mastectomy OR Breast conserving surgery

干预措施: surgical treatment 1 (Procedure)

2 Primary lesions NPCR and metastatic lesions PCR

Experimental

surgery 1 Mastectomy OR Breast conserving surgery

干预措施: surgical treatment 1 (Procedure)

3 Primary lesions PCR and metastatic lesions NPCR

Experimental

surgery 2 Resection of metastasis

干预措施: surgical treatment 2 (Procedure)

4 Primary lesions NPCR and metastatic lesions NPCR

Experimental

Systemic therapy Endocrine therapy or chemotherapy or targeted therapy

干预措施: Systemic therapy (Drug)

结局指标

主要结局

Overall survival

时间窗: 5 years

Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.

次要结局

  • Locoregional progression free survival(5 years)
  • Distant progression free survival(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yue Yu

Deputy director

Changhai Hospital

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