MedTrace Logo

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

NCT06197581 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-08-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Yirui Zhai, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Bo Lan, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Shulian Wang, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Fei Ma, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2026-01-15
Completion
2027-01-15

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06197581 on ClinicalTrials.gov