Radiation with new targeted and immune drugs for metastatic breast cancer
Official title: Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
Run by Fondazione Policlinico Universitario Campus Bio-Medico · NCT07021911 · Data updated 2026-11-12
This project will see how well radiation is tolerated when given at the same time as newer systemic drugs (targeted therapies, antibody‑drug conjugates, TKIs, or immunotherapy) in people with stage IV breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Rome, Italy) |
| Status | Recruiting |
| Started | May 17, 2023 |
| Main results expected | May 17, 2029 |
| Study ends | May 17, 2029 |
| Registry record updated | June 15, 2025 |
| Trial ID | NCT07021911 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with stage IV breast cancer who are currently receiving targeted agents, antibody‑drug conjugates, monoclonal antibodies, TKIs, or immunotherapy and who need palliative or curative radiation and are not enrolled in a systemic therapy clinical trial.
✕Probably not a fit
Patients with prior radiation to the same site, absolute contraindications to radiotherapy, or whose systemic treatment is administered within another clinical trial are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational project enrolls people with stage IV breast cancer who are receiving newer systemic agents (molecular targeted therapies, conjugated antibodies, monoclonal antibodies, TKIs, or immune checkpoint inhibitors) and who are candidates for palliative or curative radiation. Radiation treatments given during ongoing systemic therapy will be recorded and patients will be followed to document treatment‑related side effects and tolerance profiles. Key exclusions are prior radiation to the same site, absolute contraindications to radiotherapy, and systemic therapy given as part of another clinical trial. The study is performed at the Radiation Oncology Department of Fondazione Policlinico Campus Bio‑Medico in Rome, Italy.
Why it matters
Potential benefit: If successful, the results could help clinicians give combined radiation and newer systemic drugs more safely by identifying common side effects and timing risks.
How similar studies have gone: Smaller series and retrospective cohorts have suggested that combining radiotherapy with targeted agents or immunotherapy can be feasible and safe in many cases, but prospective data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients suffering from stage IV breast cancer * Ongoing systemic treatment including: molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, immunotherapy (immunocheckpoint inhibitors) * Candidates for radiation treatment (both palliative and curative). Exclusion Criteria: * Previous radiation treatment on the same site * Absolute contraindications to radiotherapy * Systemic treatment administered as part of a clinical trial
Where it's running
-
Radiation Oncology Department Fondazione Policlinico Campus BioMedico
Rome, Italy, Italy Recruiting
Study contacts
- Study coordinator: Edy Ippolito, Prof
- Email: e.ippolito@unicampus.it
- Phone: 06225418011
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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.