Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Radiotherapy; Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Radiation Radiotherapy
Conventional fractionated radiotherapy, moderate hypofractionated radiotherapy, stereotactic radiotherapy (SABR)
Primary outcome measures
- Toxicity of Radiotherapy Treatments [Time frame: Baseline, at 3, 6 month, one year from the end of radiation treatment, then yearly up to 3 years]
Secondary outcome measures (3)
- Response to Radiotherapy treatments with curative intent [Time frame: evaluated at 3 months, 6 months, 1 year from treatments]
- Pain response to Radiotherapy treatments with palliative intent [Time frame: evaluated at 3 and 6 months after treatments]
- Progression free survival (PFS) [Time frame: every 3 months after radiation treatments]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Radiation Oncology Department Fondazione Policlinico Campus BioMedico — Rome
Identifiers
NCT: NCT07021911 · PAR 73.23 OSS