Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer (COMBaRT)

Fondazione Policlinico Universitario Campus Bio-Medico

Status: Enrolling

Conditions: Breast Cancer; Radiotherapy; Complications

Treatments: Radiation: Radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT07021911

PAR 73.23 OSS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 4 patient groups

ADC's group

Description:

Patients undergoing ADC's drugs such as Trastuzumab Emtansine (TDM1), Trastuzumab Deruxtecan, Sacituzumab Govitecan

Treatment:

Radiation: Radiotherapy

Cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6 group)

Description:

Patients receiving Palbociclib or Ribociclib or Abemaciclib

Treatment:

Radiation: Radiotherapy

Anti Human Epidermal Growth Factor Receptor 2 monoclonal antibodies (Anti-Her2 group)

Description:

Patients receiving Trastuzumab or Trastuzumab Pertuzumab

Treatment:

Radiation: Radiotherapy

IT group

Description:

Patients receiving Atezolizumab or Pembrolizumab

Treatment:

Radiation: Radiotherapy