Assessing the effects of immunotherapy combined with radiotherapy in advanced breast cancer
Official title: A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06776861 · Data updated 2026-11-12
This study is testing if combining immunotherapy with radiotherapy can help people with advanced breast cancer feel better and improve their treatment results.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 24, 2024 |
| Main results expected | September 10, 2028 |
| Study ends | September 10, 2028 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT06776861 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with inoperable or metastatic advanced breast cancer who have completed radiotherapy and are receiving or planned to receive immunotherapy.
✕Probably not a fit
Patients with brain metastases or leptomeningeal metastases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study aims to evaluate the efficacy and safety of combining radiotherapy with immunotherapy in patients with advanced breast cancer. Participants will include individuals who have undergone radiotherapy and are receiving or scheduled to receive immunotherapy. The study will track patient outcomes and responses to treatment over time, providing valuable data on this combined therapeutic approach. The multicenter design allows for a diverse patient population and comprehensive data collection.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with advanced breast cancer by improving the effectiveness of immunotherapy.
How similar studies have gone: While this approach is being explored, the combination of radiotherapy and immunotherapy in advanced breast cancer is still relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Fei Ma
- Email: drmafei@126.com
- Phone: 010-87788120
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.