Assessing the effects of immunotherapy combined with radiotherapy in advanced breast cancer
A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06776861
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06776861 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with brain metastases or leptomeningeal metastases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Breast Cancer