Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer

NCT07021911 | Recruiting

• 1 other identifier: PAR 73.23 OSS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Radiotherapy; Complications

Keywords

breast cancer; radiotherapy; stereotactic radiotherapy (SABR); side effects

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (4)

ADC's group

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

Radiation: Radiotherapy

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

Patients receiving Palbociclib or Ribociclib or Abemaciclib

Radiation: Radiotherapy

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

Patients receiving Trastuzumab or Trastuzumab Pertuzumab

Radiation: Radiotherapy

IT group

Patients receiving Atezolizumab or Pembrolizumab

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Conventional fractionated radiotherapy, moderate hypofractionated radiotherapy, stereotactic radiotherapy (SABR)

ADC's group; Anti Human Epidermal Growth Factor Receptor 2 monoclonal antibodies (Anti-Her2 group); Cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6 group); IT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• 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).

You may not qualify if:

• Previous radiation treatment on the same site
• Absolute contraindications to radiotherapy
• Systemic treatment administered as part of a clinical trial

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Radiation Oncology Department Fondazione Policlinico Campus BioMedico

Rome, Italy, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Edy Ippolito, Prof

CONTACT

06225418011; e.ippolito@unicampus.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 15, 2025
• Study Start: May 17, 2023
• Primary Completion (Estimated): May 17, 2029
• Study Completion (Estimated): May 17, 2029
• Last Updated: June 15, 2025

Record last verified: 2024-10

Locations

IT (1)