Actively Recruiting
Observational Study of Radiotherapy-Sensitized Immunotherapy in Advanced Breast Cancer A Multicenter Prospective Cohort Study
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-01-15
150
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining radiotherapy with immunotherapy in patients with advanced breast cancer. This observational cohort study involves multiple centers and focuses on patients whose cancer is inoperable or has spread, and who have been recommended for radiotherapy after a thorough team evaluation. The study observes how radiotherapy may enhance the impact of immunotherapy in this advanced cancer setting. Participants include adults aged 18 and older with advanced breast cancer who have completed radiotherapy following a multidisciplinary team discussion. They must have previously received, be currently receiving, or be planned to receive immunotherapy, with systemic treatment including immunotherapy beginning within three weeks after radiotherapy. The study tracks the use of PD-1/PD-L1 monoclonal antibody drugs as part of their treatment regimen. Throughout the study, patients will be followed to monitor their progression-free survival over 24 months. Researchers will collect medical histories and observe treatment responses and safety outcomes. Participants must be able to provide informed consent and have no brain or leptomeningeal metastases. The study aims to gather important data on treatment outcomes and safety in this patient population.
CONDITIONS
Official Title
A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older who have signed informed consent
- Diagnosed with inoperable or metastatic advanced breast cancer confirmed by histology or cytology
- Considered suitable for and have completed radiotherapy after multidisciplinary team evaluation at metastatic breast cancer stage
- Have received or are planned to receive immunotherapy and scheduled for systemic treatment including immunotherapy within 3 weeks after radiotherapy
- Have a traceable medical history during treatment
- Able to provide informed consent to participate in the study
You will not qualify if you...
- Presence of brain metastases or leptomeningeal metastases confirmed by cranial MRI if symptoms suggest CNS involvement
- Have not signed the informed consent form
- Pregnant or lactating women
- Any other conditions considered unsuitable for study inclusion by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
F
Fei Ma
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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