About this trial
A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women who are 18 years of age or older on the day of signing the informed consent;
Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;
Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;
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;
Disqualifiers
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;
Have not signed the informed consent form;
Pregnant or lactating women;
Other conditions deemed unsuitable for inclusion in the study by the investigator.
Trial population
Patients with advanced breast cancer who have already received and continue to use immunotherapy, or are planned to receive immunotherapy, and have been recommended for radiotherapy following evaluation by a multidisciplinary team (MDT) in the early stage and have completed radiotherapy, are registered and followed up in this study.
Trial design
Cohort
Prospective
Treatments tested in this trial
PD-1 / PD-L1 monoclonal antibody
DrugPatients with advanced breast cancer who have already received and continue to use immunotherapy, or are planned to receive immunotherapy, and have been recommended for radiotherapy after evaluation by a multidisciplinary team (MDT) in the early stage and have completed radiotherapy, are registered and followed up in this study.
Treatment groups
Trial outcomes
Primary outcomes
Progression-Free Survival
According to RECIST 1.1 criteria:Disease Progression (PD): Referring to the smallest sum of the diameters of all measured target lesions throughout the entire experimental study, there is a relative increase of at least 20% in the sum of the diameters (if the baseline measurement is the smallest, then the baseline value is used as the reference); in addition, there must be an absolute increase of at least 5 mm in the sum of the diameters (the appearance of one or more new lesions is also considered disease progression).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.