A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.
Investigators
Ma Fei，MD
Deputy Director of the Department of Medical Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Subjects are eligible for inclusion in the study only if all the following criteria apply:
- •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;
- •Patients with a traceable medical history during treatment;
- •Subjects who are able to sign an informed consent to participate in the study.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Progression-Free Survival
Time Frame: 24 months
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).