Breast Cancer, Radiotherapy; Complications
Conditions
Keywords
breast cancer, radiotherapy, stereotactic radiotherapy (SABR), side effects
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.
Interventions
RADIATIONRadiotherapy
Conventional fractionated radiotherapy, moderate hypofractionated radiotherapy, stereotactic radiotherapy (SABR)
Sponsors
Fondazione Policlinico Universitario Campus Bio-Medico
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactEdy Ippolito, Prof
Outcome results
None listed