RecruitingNot ApplicableNCT06197581

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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

148 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the safety of combining radiation therapy with newer systemic treatments for breast cancer, including CDK4/6 inhibitors, PARP inhibitors, immunotherapy, and HER2-targeted drugs. Doctors want to know if these combinations cause more side effects than expected. **You may be eligible if...** - You are a woman, 18–70 years old - You have been diagnosed with breast cancer (any stage) - You need radiation to the chest wall or breast (with or without lymph nodes) per standard guidelines - You are also receiving one of the following: capecitabine, CDK4/6 inhibitor, PARP inhibitor, immunotherapy, or HER2-targeted therapy **You may NOT be eligible if...** - You are male - You have allergies to the study drugs - You are receiving trastuzumab alone during radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONChest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)

Patients will receive chest wall / breast radiation with or without lymph node region radiation and novel drugs(for specific population according to guidelines) concurrently.


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 Municipality, China

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NCT06197581


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