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临床试验/NCT06197581
NCT06197581招募中不适用

Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2024年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
148
试验地点
1
主要终点
Grade 3 adverse events

研究概览

简要总结

Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4/6 inhibitors, PARP inhibitors, capecitabine and PD1 inhibitors have greatly improved the prognosis of breast cancer and has become the standard treatment for specific populations. A considerable number of patients require both radiotherapy and maintenance systemic therapy. However, it is not clear whether systemic therapy should be synchronized or suspended in radiotherapy,despite that previous basic research shows that some molecular drug therapy and radiotherapy has a clear synergy mechanism. There is an agent need for a definite evidence to evaluate the safety of synchronous treatment, to support clinical diagnosis and treatment and the next step of comprehensive treatment. The implementation of the new radiotherapy technology represented by IMRT takes into account the prescription dose homogenization and the minimization of normal tissue dosage, which provides a certain basis for the combination therapy. Based on the above conditions, this study intends to enroll patients between 18 and 70 years old with chest wall / breast ± lymphatic drainage area and requiring capecitabine, CDK 4/ 6 inhibitor, HER2 targeted therapy or immunotherapy. Radiation and novel systemic therapies would be delivered concurrently. The study aimed at evaluating the safety of combined treatments.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 18-70 years old. Pathologically diagnosed as breast cancer. Need to receive radiotherapy according to guidelines. Radiotherapy target volume included chest wall/breast with or without lymph node regions.
  • Need to receive one of the following therapies according to guidelines, capetabine, CDK4/6 inhibitor, PARP inhibitor , ICIs , HER2 inhibitors.

排除标准

  • Male breast cancer. Allergy to the upper medicines before. Will receive trastuzumab alone during and/or after radiotherapy. With severe other disease.

结局指标

主要结局

Grade 3 adverse events

时间窗: Every week during the radiation , week 4 and week 12 after radiation, and at any time when severe symptoms were recorded within 3 months after radiation.

To investigate the adverse events and safety of the combined treatment.

次要结局

  • Adverse events with any grade(Every week during the radiation , week 4 and week 12 after radiation, and at any time when severe symptoms were recorded within 3 months after radiation)

研究者

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

Yirui Zhai,MD.

Associate Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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