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

NCT ID: NCT06197581

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-12
• Study Completion Date: 2027-01-15

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT+capecitabine

Patients will receive concurrent radiotherapy and capecitabine.

Group Type: OTHER

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

Intervention Type: 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.

RT+HER2 inhibitors

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

Group Type: OTHER

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

Intervention Type: 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.

RT+ CDK4/6 inhibitors

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

Group Type: OTHER

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

Intervention Type: 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.

RT+PARP inhibitor.

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

Group Type: OTHER

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

Intervention Type: 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.

RT+ICI

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

Group Type: OTHER

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

Intervention Type: 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.

Interventions

Chest 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.

Intervention Type: RADIATION

Other Intervention Names

capecitabine（For Arm RT+capecitabine）; HER2 inhibitors (For Arm RT+HER2 inhibitors); CDK4/6 inhibitors(For Arm RT+CDK4/6 inhibitors); PARP inhibitors（For Arm RT+PARP inhibitor）; ICIs(For RT+ICI)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Yirui Zhai,MD.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yirui Zhai, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Bo Lan, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Shulian Wang, MD

Role: STUDY_CHAIR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Fei Ma, MD

Role: STUDY_CHAIR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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

Site Status: RECRUITING

Countries

China

Central Contacts

Yirui Zhai, MD

Role: CONTACT

januarywind@163.com

+86-10-87788058

Bo Lan, MD

Role: CONTACT

Facility Contacts

Yirui Zhai, MD

Role: primary

januarywind@163.com

+86-10-87788058

Bo Lan, MD.

Role: backup

daxiaolanbo@163.com

References

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Reference Type: RESULT

PMID: 35020465 (View on PubMed)

Other Identifiers

NCC4214；Approve No.23/384-4216

Identifier Type: -

Identifier Source: org_study_id