Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer

NCT ID: NCT07021911

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-17

Study Completion Date

2029-05-17

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Breast Cancer Radiotherapy; Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ADC's group

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

Radiotherapy

Intervention Type RADIATION

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

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

Patients receiving Palbociclib or Ribociclib or Abemaciclib

Radiotherapy

Intervention Type RADIATION

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

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

Patients receiving Trastuzumab or Trastuzumab Pertuzumab

Radiotherapy

Intervention Type RADIATION

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

IT group

Patients receiving Atezolizumab or Pembrolizumab

Radiotherapy

Intervention Type RADIATION

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

Interventions

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Radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radiation Oncology Department Fondazione Policlinico Campus BioMedico

Rome, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Edy Ippolito, Prof

Role: CONTACT

06225418011

Facility Contacts

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Edy Ippolito, Prof

Role: primary

06/225418011

Other Identifiers

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PAR 73.23 OSS

Identifier Type: -

Identifier Source: org_study_id

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