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NCT06776861
A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Conditions: Advanced Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Location: Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality
Summary
A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06776861). StuddyBuddy aggregates publicly available trial information.