Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer

Recruiting

• Conditions: Breast Cancer; Radiotherapy; Complications

• Registration Number: NCT07021911
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

Brief 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.

Study Timeline

• Study Start: 2023-05-17
• Status Verified: 2024-10
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15
• Primary Completion: 2029-05-17
• Study Completion: 2029-05-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity of Radiotherapy Treatments	Baseline, at 3, 6 month, one year from the end of radiation treatment, then yearly up to 3 years	Acute and Late Toxicity evaluated with CTCAE (Common Terminology Criteria for Adverse Events) scale v6.0

Secondary Outcome Measures

Name	Time	Method
Response to Radiotherapy treatments with curative intent	evaluated at 3 months, 6 months, 1 year from treatments	Response classified according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria
Pain response to Radiotherapy treatments with palliative intent	evaluated at 3 and 6 months after treatments	Pain response classified according to NRS (Numering Pain Rating Scale); this scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores correspond to worse outcomes.
Progression free survival (PFS)	every 3 months after radiation treatments	assessed from the start of radiation treatment to progression, local recurrence, or death, whichever comes first.

Trial Locations

Locations (1)

Radiation Oncology Department Fondazione Policlinico Campus BioMedico; 🇮🇹 Rome, Italy