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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC's group | Patients undergoing ADC's drugs such as Trastuzumab Emtansine (TDM1), Trastuzumab Deruxtecan, Sacituzumab Govitecan |
| |
| Cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6 group) | Patients receiving Palbociclib or Ribociclib or Abemaciclib |
| |
| Anti Human Epidermal Growth Factor Receptor 2 monoclonal antibodies (Anti-Her2 group) | Patients receiving Trastuzumab or Trastuzumab Pertuzumab |
| |
| IT group | Patients receiving Atezolizumab or Pembrolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Conventional fractionated radiotherapy, moderate hypofractionated radiotherapy, stereotactic radiotherapy (SABR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of Radiotherapy Treatments | Acute and Late Toxicity evaluated with CTCAE (Common Terminology Criteria for Adverse Events) scale v6.0 | Baseline, at 3, 6 month, one year from the end of radiation treatment, then yearly up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response to Radiotherapy treatments with curative intent | Response classified according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria | evaluated at 3 months, 6 months, 1 year from treatments |
| Pain response to Radiotherapy treatments with palliative intent |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from stage IV breast cancer undergoing systemic treatment including: molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, immunotherapy (immunocheckpoint inhibitors)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edy Ippolito, Prof | Contact | 06225418011 | e.ippolito@unicampus.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology Department Fondazione Policlinico Campus BioMedico | Recruiting | Rome | Italy | 00128 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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. |
| evaluated at 3 and 6 months after treatments |
| Progression free survival (PFS) | assessed from the start of radiation treatment to progression, local recurrence, or death, whichever comes first. | every 3 months after radiation treatments |
| D017437 |
| Skin and Connective Tissue Diseases |