Liver MetastasesHoLiBreastNCT06142344
Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients
A study testing Quiremspheres™ in people with Liver Metastases and Breast Cancer, run by The Netherlands Cancer Institute at 2 sites in 2 countries.
Trial summary
The goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer. Participants will receive a mapping angiography and Ho-166 radioembolization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Liver Metastases, Breast Cancer
- What is being tested?
- Quiremspheres™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Oct 2023to 19 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women >18 years
- Patients with hormone positive and HER2 negative liver metastatic breast cancer
- No extra-hepatic disease progression at evaluation of at least second line systemic chemotherapy
- Suitable for TARE evaluated after the mapping angiography
- Measurable target tumors in the liver according to RECIST 1.1
- Liver tumor burden <50 %
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- ECOG performance score 0 to 1
- Laboratory parameters: neutrophils >1000/μL; thrombocyte count >1000000 μL; eGFR >45/mL/min/1.73 m2; albumin > 3.0 g/dl, bilirubin < 1.5x ULN (unless Gilbert syndrome); aminotransferase (ALAT/ASAT) <3.0 ULN
- Able to read Dutch
Who cannot join
- Life expectancy ≤3 months
- Patient eligible for other curative local liver therapy (ea. surgery, ablation)
- Brain, pleural, peritoneal or extensive extra-hepatic visceral metastases
- Other life-threatening disease (i.e. Dialysis, unresolved diarrhea, serious unresolved infections (HIV, HBV, HCV etc.))
- Contraindication for angiography or MRI
- Significant toxicities due to prior cancer therapy that have not resolved before the initiation of the study, if the investigator determines that the continuing complication will compromise the safe treatment of the patient
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- Prior or planned embolic intra-arterial liver directed therapy (TACE, TAE, TARE)
- Prior or planned external or internal radiation therapy of the liver
- Cirrhosis or portal hypertension
- Main portal vein thrombosis
- Intervention for, or compromise of, the Ampulla of Vater
- Ascites (except minor focal ascites)
- Baseline use of analgesics for abdominal pain
- Pregnancy (Women at childbearing potential need at least one form of birth control) and breastfeeding
- Flow to extra hepatic vessels not correctable by reposition or embolization
- Estimated dose to the lungs greater than 30 Gy in a single administration or 50 Gy cumulatively
- Target tumoral absorbed dose of < 90Gy or an absorbed dose to the normal liver parenchyma of >50Gy (in case of whole liver treatment)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Not yet recruiting
University Hospital Leuven
Leuven, Vlaams-Brabant, 3000
Geert Maleux, MD, Prof
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX
Elizabeth G Klompenhouwer, MD, PhD, holibreast@nki.nl
About this study
Official title: The Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients
The goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer.
Participants will receive a mapping angiography and Ho-166 radioembolization. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.
- Conditions
- Liver Metastases, Breast Cancer
- Being tested
- Quiremspheres™
- Keywords
- Liver metastatic breast cancer, Holmium-166, Radioembolization, TARE, SIRT, Selective internal radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quiremspheres™Device
Also called Radioembolization with Quiremspheres™
The intervention comprises two steps. Initially, the patient will undergo mapping angiography and a Ho-166 scout dose. If deemed eligible, the patient will proceed to 166-Ho radioembolization.
| Study group | Role | What they receive |
|---|---|---|
| Ho-166 radioembolization | Experimental | Patients will undergo standard procedures for holmium radioembolization Receives: Device: Quiremspheres™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The percentage of patients were radioembolization and systemic chemotherapy is safely feasible. Safety is defined as percentage of 90 day post-radioembolization (CTCAE/SIR grade 3 or higher) which lead discontinuation of the current systemic chemotherapy. Time to re-start chemotherapy after intervention in days will be collected.
Measured: Up to 3 months after intervention
Secondary outcomes (3)
Lesion- and patient-based response
Radiological response on contrast-enhanced CT and MRI measured by RECIST
Measured: Up to 3 months after intervention
Overall toxicity associated with study intervention
Graded by CTCAE/SIR grade
Measured: Up to 3 months after intervention
Quality of Life during study
Obtained by EORTC QLQ-C30 questionnaire
Measured: From start inclusion to 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start19 Oct 2023
- Primary completion19 Oct 2025 (estimated)
- Study completion19 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142344
- Sponsor's protocol ID
- M21RTA
- Acronym
- HoLiBreast
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06142344
- Acronym / sponsor ID
- HoLiBreast / M21RTA
- Conditions
- Liver Metastases, Breast Cancer
- Keywords
- Liver metastatic breast cancer, Holmium-166, Radioembolization, TARE, SIRT, Selective internal radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 19 Oct 2025 (estimated)
- Study completion
- 19 Jan 2026 (estimated)
- First posted
- 21 Nov 2023 (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 goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer.
Participants will receive a mapping angiography and Ho-166 radioembolization. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ho-166 radioembolization | Experimental | Device: Quiremspheres™Patients will undergo standard procedures for holmium radioembolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women >18 years
- Patients with hormone positive and HER2 negative liver metastatic breast cancer
- No extra-hepatic disease progression at evaluation of at least second line systemic chemotherapy
- Suitable for TARE evaluated after the mapping angiography
- Measurable target tumors in the liver according to RECIST 1.1
Key exclusion criteria (17 listed)
- Life expectancy ≤3 months
- Patient eligible for other curative local liver therapy (ea. surgery, ablation)
- Brain, pleural, peritoneal or extensive extra-hepatic visceral metastases
- Other life-threatening disease (i.e. Dialysis, unresolved diarrhea, serious unresolved infections (HIV, HBV, HCV etc.))
- Contraindication for angiography or MRI
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 |
|---|---|---|
| Quiremspheres™Also: Radioembolization with Quiremspheres™The intervention comprises two steps. Initially, the patient will undergo mapping angiography and a Ho-166 scout dose. If deemed eligible, the patient will proceed to 166-Ho radioembolization. | Device | Ho-166 radioembolization |
Primary outcome
Feasibility
Time frame: Up to 3 months after intervention
The percentage of patients were radioembolization and systemic chemotherapy is safely feasible. Safety is defined as percentage of 90 day post-radioembolization (CTCAE/SIR grade 3 or higher) which lead discontinuation of the current systemic chemotherapy. Time to re-start chemotherapy after intervention in days will be collected.
3 secondary outcomes
Lesion- and patient-based response
Time frame: Up to 3 months after intervention
Overall toxicity associated with study intervention
Time frame: Up to 3 months after intervention
Quality of Life during study
Time frame: From start inclusion to 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quiremspheres™ in people with Liver Metastases and Breast Cancer, run by The Netherlands Cancer Institute at 2 sites in 2 countries.
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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth G Klompenhouwer, MD, PhD (+31205129111, holibreast@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Up to 3 months after intervention). 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 21 Nov 2023.