Breast CancerCOMBaRTNCT07021911
Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
An observational study of Breast Cancer and Radiotherapy; Complications, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Radiotherapy; Complications
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2023to 17 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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).
Who cannot join
- Previous radiation treatment on the same site
- Absolute contraindications to radiotherapy
- Systemic treatment administered as part of a clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Radiation Oncology Department Fondazione Policlinico Campus BioMedico
Rome, Italy, 00128
Edy Ippolito, Prof, 06/225418011, e.ippolito@unicampus.it
About this study
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).
Read the detailed 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.
- Conditions
- Breast Cancer, Radiotherapy; Complications
- Being tested
- Radiotherapy
- Keywords
- breast cancer, radiotherapy, stereotactic radiotherapy (SABR), side effects
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Conventional fractionated radiotherapy, moderate hypofractionated radiotherapy, stereotactic radiotherapy (SABR)
| Study group | Role | What they receive |
|---|---|---|
| ADC's group | Patients undergoing ADC's drugs such as Trastuzumab Emtansine (TDM1), Trastuzumab Deruxtecan, Sacituzumab Govitecan Receives: Radiation: Radiotherapy | |
| Cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6 group) | Patients receiving Palbociclib or Ribociclib or Abemaciclib Receives: Radiation: Radiotherapy | |
| Anti Human Epidermal Growth Factor Receptor 2 monoclonal antibodies (Anti-Her2 group) | Patients receiving Trastuzumab or Trastuzumab Pertuzumab Receives: Radiation: Radiotherapy | |
| IT group | Patients receiving Atezolizumab or Pembrolizumab Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity of Radiotherapy Treatments
Acute and Late Toxicity evaluated with CTCAE (Common Terminology Criteria for Adverse Events) scale v6.0
Measured: 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
Response classified according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria
Measured: evaluated at 3 months, 6 months, 1 year from treatments
Pain response to Radiotherapy treatments with palliative intent
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.
Measured: 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.
Measured: every 3 months after radiation treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start17 May 2023
- Primary completion17 May 2029 (estimated)
- Study completion17 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021911
- Sponsor's protocol ID
- PAR 73.23 OSS
- Acronym
- COMBaRT
- Status last verified
- Oct 2024
- First submitted
- 7 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07021911
- Acronym / sponsor ID
- COMBaRT / PAR 73.23 OSS
- Conditions
- Breast Cancer, Radiotherapy; Complications
- Keywords
- breast cancer, radiotherapy, stereotactic radiotherapy (SABR), side effects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 17 May 2029 (estimated)
- Study completion
- 17 May 2029 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADC's group | – | Radiation: RadiotherapyPatients undergoing ADC's drugs such as Trastuzumab Emtansine (TDM1), Trastuzumab Deruxtecan, Sacituzumab Govitecan |
| Cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6 group) | – | Radiation: RadiotherapyPatients receiving Palbociclib or Ribociclib or Abemaciclib |
| Anti Human Epidermal Growth Factor Receptor 2 monoclonal antibodies (Anti-Her2 group) | – | Radiation: RadiotherapyPatients receiving Trastuzumab or Trastuzumab Pertuzumab |
| IT group | – | Radiation: RadiotherapyPatients receiving Atezolizumab or Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Previous radiation treatment on the same site
- Absolute contraindications to radiotherapy
- Systemic treatment administered as part of a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyConventional fractionated radiotherapy, moderate hypofractionated radiotherapy, stereotactic radiotherapy (SABR) | Radiation | 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 |
Primary outcome
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
3 secondary outcomes
Response to Radiotherapy treatments with curative intent
Time frame: evaluated at 3 months, 6 months, 1 year from treatments
Pain response to Radiotherapy treatments with palliative intent
Time frame: evaluated at 3 and 6 months after treatments
Progression free survival (PFS)
Time frame: every 3 months after radiation treatments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiotherapy; Complications, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edy Ippolito, Prof (06225418011, e.ippolito@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.