Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Toxicity of Radiotherapy Treatments
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
Acute and Late Toxicity evaluated with CTCAE (Common Terminology Criteria for Adverse Events) scale v6.0
Secondary Outcomes
- Response to Radiotherapy treatments with curative intent(evaluated at 3 months, 6 months, 1 year from treatments)
- Pain response to Radiotherapy treatments with palliative intent(evaluated at 3 and 6 months after treatments)
- Progression free survival (PFS)(every 3 months after radiation treatments)