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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Advanced Breast Cancer

Treatments: Drug: PD-1 / PD-L1 monoclonal antibody

Study type: Observational

Funder types: Other

Identifiers

NCT06776861

NCC4908

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 informed consent;
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, are considered suitable for radiotherapy and have completed radiotherapy;
4. Patients who have previously received and continue to use immunotherapy, or are planned to receive immunotherapy, and are scheduled to receive a systemic treatment regimen including immunotherapy as chosen by the physician within 3 weeks after completing 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 criteria

1. Subjects with brain metastases or leptomeningeal metastases; if there are any suspected symptoms or signs of CNS involvement, they should be excluded by a cranial MRI 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.