A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer

Last updated: January 14, 2025
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

PD-1 / PD-L1 monoclonal antibody

Clinical Study ID

NCT06776861
NCC4908
  • Ages > 18
  • All Genders

Study Summary

A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects are eligible for inclusion in the study only if all the following criteria apply:

  1. Men or women who are 18 years of age or older on the day of signing the informedconsent;

  2. Patients with advanced breast cancer that is inoperable or has metastasized,confirmed by histology or cytology;

  3. Patients who, after MDT discussion at the metastatic breast cancer stage, areconsidered suitable for radiotherapy and have completed radiotherapy;

  4. Patients who have previously received and continue to use immunotherapy, or areplanned to receive immunotherapy, and are scheduled to receive a systemic treatmentregimen including immunotherapy as chosen by the physician within 3 weeks aftercompleting radiotherapy;

  5. Patients with a traceable medical history during treatment;

  6. Subjects who are able to sign an informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  1. Subjects with brain metastases or leptomeningeal metastases; if there are anysuspected symptoms or signs of CNS involvement, they should be excluded by a cranialMRI scan;

  2. Have not signed the informed consent form;

  3. Pregnant or lactating women;

  4. Other conditions deemed unsuitable for inclusion in the study by the investigator.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: PD-1 / PD-L1 monoclonal antibody
Phase:
Study Start date:
September 24, 2024
Estimated Completion Date:
September 10, 2028

Connect with a study center

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

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