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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Radiation

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

Treatment groups

148 Participants
are divided into 5 treatment groups
Group A: RT+capecitabineOther 1 intervention
Group B: RT+HER2 inhibitorsOther 1 intervention
Group C: RT+ CDK4/6 inhibitorsOther 1 intervention
Group D: RT+PARP inhibitor.Other 1 intervention
Group E: RT+ICIOther 1 intervention

Trial outcomes

Primary outcomes

1

Grade 3 adverse events

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

Time frame
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.

Secondary outcomes

1

Adverse events with any grade

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

Time frame
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

Other outcomes

Sponsors and contacts

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