Actively Recruiting
Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-06-15
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with stage IV breast cancer who are receiving new systemic treatments including molecular targeted therapies, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, and immunotherapy. It aims to study the tolerance and side effects of radiation treatments given alongside these new drugs. The study is observational and sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. Participants receive radiation treatments which may be conventional fractionated radiotherapy, moderate hypofractionated radiotherapy, or stereotactic radiotherapy (SABR). The study includes groups of patients based on the systemic therapy they receive, such as those on antibody-drug conjugates, CDK4/6 inhibitors, anti-Her2 monoclonal antibodies, or immunotherapy agents. Radiation treatment can be given for either palliative or curative purposes. During the study, researchers will monitor the toxicity of radiation treatments at baseline, 3, 6, and 12 months after radiation ends, then yearly up to 3 years. They will also assess responses to curative radiotherapy at 3, 6, and 12 months and pain relief from palliative radiotherapy at 3 and 6 months. Progression-free survival will be tracked every 3 months after radiation. Participants will have regular evaluations to follow their tolerance and outcomes over time.
CONDITIONS
Brief Title
Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients suffering from stage IV breast cancer
- Ongoing systemic treatment including molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, or immunotherapy
- Candidates for radiation treatment, either palliative or curative
You will not qualify if you...
- Previous radiation treatment on the same site
- Absolute contraindications to radiotherapy
- Systemic treatment administered as part of a clinical trial
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.
Duration - Varies according to radiation treatment schedule
Participants receive radiation treatments, which may include conventional fractionated radiotherapy, moderate hypofractionated radiotherapy, or stereotactic radiotherapy (SABR), while continuing their systemic therapy.
Radiotherapy visits as per individual treatment plans
Duration - Up to 3 years after radiation treatment
Participants are monitored for tolerance and response to radiotherapy as well as progression-free survival after completing radiation treatments.
Visits at 3 months, 6 months, 1 year, and yearly up to 3 years after radiation treatment
Trial Site Locations
Total: 1 location
1
Radiation Oncology Department Fondazione Policlinico Campus BioMedico
Rome, Italy, Italy, 00128
Actively Recruiting
Research Team
E
Edy Ippolito, Prof
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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