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NCT Number: NCT07021911

Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Radiotherapy; Complications Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiation Oncology Department Fondazione Policlinico Campus BioMedico

Rome, Italy, 00128

Location status: Recruiting

Location contact

Edy Ippolito, Prof

CONTACT

[email protected]

06/225418011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

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

Primary outcomes

  1. 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

  1. Response to Radiotherapy treatments with curative intent

    Time frame: evaluated at 3 months, 6 months, 1 year from treatments

    Response classified according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria

  2. Pain response to Radiotherapy treatments with palliative intent

    Time frame: evaluated at 3 and 6 months after treatments

    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.

  3. Progression free survival (PFS)

    Time frame: every 3 months after radiation treatments

    assessed from the start of radiation treatment to progression, local recurrence, or death, whichever comes first.

Study contacts

Contact information is provided by the study sponsor or research team.

Edy Ippolito, Prof

CONTACT

[email protected]

06225418011

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Other

Registry information

Acronym: COMBaRT

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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