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

August 19, 2024 updated by: Yirui Zhai,MD., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bo Lan, MD

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RT+capecitabine
Patients will receive concurrent radiotherapy and capecitabine.
Radiation: 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.
Other 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)
Other: RT+HER2 inhibitors
Patients will receive concurrent radiotherapy and any HER2 inhibitors ( eg. trastuzumab plus pertuzumab or TDM1)
Radiation: 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.
Other 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)
Other: RT+ CDK4/6 inhibitors
Patients will receive concurrent radiotherapy and any of the CDK4/6 inhibitors (abemaciclib，palbociclib ,ribociclib or other CDK4/6 inhibitors)
Radiation: 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.
Other 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)
Other: RT+PARP inhibitor.
Patients will receive concurrent radiotherapy and PARP inhibitor(Olaparib or other PARP inhibitors)
Radiation: 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.
Other 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)
Other: RT+ICI
Patients will receive concurrent radiotherapy and immune checkpoint inhibitor (Pembrolizumab or other anti-PD1/PDL1 regimens).
Radiation: 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.
Other 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 3 adverse events
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.
To investigate the adverse events and safety of the combined treatment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events with any grade
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
To investigate the adverse events and safety of the combined treatment.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Yirui Zhai, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Principal Investigator: Bo Lan, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Study Chair: Shulian Wang, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Study Chair: Fei Ma, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4214；Approve No.23/384-4216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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