Radiation with new targeted and immune drugs for metastatic breast cancer
Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
Fondazione Policlinico Universitario Campus Bio-Medico · NCT07021911
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico (other) |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT07021911 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome, Italy
- 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
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: Breast Cancer, Radiotherapy, Complications, breast cancer, radiotherapy, stereotactic radiotherapy, side effects