Actively Recruiting
A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-01-15
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of radiotherapy-sensitized immunotherapy in adults with advanced breast cancer that cannot be operated on or has spread to other parts of the body. This observational study aims to assess how effective and safe this combined treatment approach is for these patients. The research is being conducted across multiple centers to gather broad data on treatment outcomes. The study involves patients who have received or are planned to receive immunotherapy, specifically PD-1 / PD-L1 monoclonal antibodies, along with radiotherapy. These participants have been evaluated by a multidisciplinary team and have completed radiotherapy before continuing or starting systemic immunotherapy within three weeks. The study follows patients who are undergoing this treatment regimen as determined by their doctors. Participants will be registered and followed over time to monitor their treatment response and safety. Researchers will collect medical history and treatment information to measure progression-free survival over 24 months. The study requires informed consent and tracks patients who have completed radiotherapy and are receiving immunotherapy. This ongoing observation helps understand the combined treatment effects and patient outcomes.
CONDITIONS
Brief 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 18 years or older on the day of signing informed consent
- Diagnosed with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology
- Considered suitable for radiotherapy after multidisciplinary team discussion and have completed radiotherapy
- Have received and continue to use immunotherapy, or are planned to receive immunotherapy, with systemic treatment including immunotherapy starting within 3 weeks after radiotherapy
- Have a traceable medical history during treatment
- Able to sign informed consent to participate in the study
You will not qualify if you...
- Presence of brain metastases or leptomeningeal metastases; suspected central nervous system involvement must be excluded by cranial MRI
- Have not signed the informed consent form
- Pregnant or lactating women
- Other conditions deemed unsuitable for study inclusion by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who have completed radiotherapy and receive immunotherapy are observed to assess treatment efficacy and safety.
Regular visits as per routine care
Duration - Up to 24 months
Participants are monitored for progression-free survival and safety after the completion of treatment observation.
Visits according to standard clinical follow-up
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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