NCT07021911

Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to describe the tolerance profile of radiation treatments performed during systemic treatment with new drugs (molecular targeted therapies, immunotherapy, others).

Detailed description

Patients suffering from stage IV breast cancer undergoing a systemic treatment including: molecular targeted therapy, conjugated antibodies (ADCs), monoclonal antibodies, tyrosine kinase inhibitors (TKI), immunotherapy (ICIs), who are candidates for a radiation treatment (both palliative or curative), after being informed about the study and giving written informed consent, will be considered eligible for this observational study. This study aims to prospectively analyze the tolerance profile of radiation treatments performed during new generation systemic therapy.

Conditions

• Breast Cancer
• Radiotherapy; Complications

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Conventional fractionated radiotherapy, moderate hypofractionated radiotherapy, stereotactic radiotherapy (SABR)

Timeline

• Start date: 2023-05-17
• Primary completion: 2029-05-17
• Completion: 2029-05-17
• First posted: 2025-06-15
• Last updated: 2025-06-15

Locations

1 site across 1 country: Italy