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

Not Applicable

Recruiting

• Conditions: Breast Cancer, Familial Male; Immune Checkpoint Inhibitor; CDK4/6 Inhibitor; Radiotherapy; Complications; Chemotherapeutic Toxicity; Trastuzumab; Pertuzumab; PARP Inhibitor
• Interventions: Radiation: Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)

• Registration Number: NCT06197581
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-26
• Study First Posted: 2024-01-09
• Study Start: 2024-01-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-01-15
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RT+ CDK4/6 inhibitors	Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)	Patients will receive concurrent radiotherapy and any of the CDK4/6 inhibitors (abemaciclib，palbociclib ,ribociclib or other CDK4/6 inhibitors)
RT+HER2 inhibitors	Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)	Patients will receive concurrent radiotherapy and any HER2 inhibitors ( eg. trastuzumab plus pertuzumab or TDM1)
RT+ICI	Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)	Patients will receive concurrent radiotherapy and immune checkpoint inhibitor (Pembrolizumab or other anti-PD1/PDL1 regimens).
RT+capecitabine	Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)	Patients will receive concurrent radiotherapy and capecitabine.
RT+PARP inhibitor.	Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)	Patients will receive concurrent radiotherapy and PARP inhibitor(Olaparib or other PARP inhibitors)

Primary Outcome Measures

Name	Time	Method
Grade 3 adverse events	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.

Secondary Outcome Measures

Name	Time	Method
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	To investigate the adverse events and safety of the combined treatment.

Trial Locations

Locations (1)

Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China