Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Campus Bio-Medico
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Previous radiation treatment on the same site
Absolute contraindications to radiotherapy
Systemic treatment administered as part of a clinical trial
Trial population
Patients suffering from stage IV breast cancer undergoing systemic treatment including: molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, immunotherapy (immunocheckpoint inhibitors)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Radiotherapy
RadiationConventional fractionated radiotherapy, moderate hypofractionated radiotherapy, stereotactic radiotherapy (SABR)
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: ADC's group1 intervention
Group B: Cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6 group)1 intervention
Group C: Anti Human Epidermal Growth Factor Receptor 2 monoclonal antibodies (Anti-Her2 group)1 intervention
Group D: IT group1 intervention
Trial outcomes
Primary outcomes
1
Toxicity of Radiotherapy Treatments
Acute and Late Toxicity evaluated with CTCAE (Common Terminology Criteria for Adverse Events) scale v6.0
Time frame
Baseline, at 3, 6 month, one year from the end of radiation treatment, then yearly up to 3 yearsSecondary outcomes
1
Response to Radiotherapy treatments with curative intent
Response classified according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria
Time frame
evaluated at 3 months, 6 months, 1 year from treatments2
Pain response to Radiotherapy treatments with palliative intent
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.
Time frame
evaluated at 3 and 6 months after treatments3
Progression free survival (PFS)
assessed from the start of radiation treatment to progression, local recurrence, or death, whichever comes first.
Time frame
every 3 months after radiation treatmentsSponsors and contacts
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Source ClinicalTrials.gov