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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Pertuzumab; Breast Cancer, Familial Male; CDK4/6 Inhibitor; Immune Checkpoint Inhibitor; Radiotherapy; Complications; Chemotherapeutic Toxicity; PARP Inhibitor; Trastuzumab

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06197581

NCC4214；Approve No.23/384-4216

Details and patient eligibility

About

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.

Enrollment: 148 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 5 patient groups

RT+capecitabine

Other group

Description:

Patients will receive concurrent radiotherapy and capecitabine.

Treatment:

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

RT+HER2 inhibitors

Other group

Description:

Patients will receive concurrent radiotherapy and any HER2 inhibitors ( eg. trastuzumab plus pertuzumab or TDM1)

Treatment:

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

RT+ CDK4/6 inhibitors

Other group

Description:

Patients will receive concurrent radiotherapy and any of the CDK4/6 inhibitors (abemaciclib，palbociclib ,ribociclib or other CDK4/6 inhibitors)

Treatment:

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

RT+PARP inhibitor.

Other group

Description:

Patients will receive concurrent radiotherapy and PARP inhibitor(Olaparib or other PARP inhibitors)

Treatment:

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

RT+ICI

Other group

Description:

Patients will receive concurrent radiotherapy and immune checkpoint inhibitor (Pembrolizumab or other anti-PD1/PDL1 regimens).

Treatment:

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