Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer
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 treat
| Condition(s) | Breast Cancer, Familial Male, Radiotherapy; Complications, Chemotherapeutic Toxicity, Immune Checkpoint Inhibitor, CDK4/6 Inhibitor, Trastuzumab, Pertuzumab, PARP Inhibitor |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: ECOG 0-2. 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. Exclusion Criteria: Male breast cancer. Allergy to the upper medicines before. Will receive trastuzumab alone during and/or after radiotherapy. With severe other disease. |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-01-12 |
| NCT ID | NCT06197581 |
| Official listing | https://clinicaltrials.gov/study/NCT06197581 |