Combining radioembolization with chemotherapy for liver metastatic breast cancer
The Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients
This study is testing if adding a special type of radiation treatment to chemotherapy can help women with liver metastatic breast cancer feel better and manage their tumors more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Leuven, Vlaams-Brabant and 1 other locations) |
| Trial ID | NCT06142344 on ClinicalTrials.gov |
What this trial studies
This multicenter pilot study aims to evaluate the feasibility of adding Holmium-166 radioembolization to chemotherapy in women with liver metastatic breast cancer. Participants will undergo mapping angiography followed by radioembolization, with chemotherapy paused 2-5 days prior to the procedure. The continuation of chemotherapy will be assessed two weeks after the radioembolization. The study focuses on patients with hormone-positive and HER2-negative tumors who have a manageable liver tumor burden.
Who should consider this trial
Good fit: Ideal candidates are women over 18 with hormone-positive, HER2-negative liver metastatic breast cancer and no extra-hepatic disease progression.
Not a fit: Patients with a life expectancy of three months or less or those eligible for other curative local liver therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with liver metastatic breast cancer.
How similar studies have performed: While the combination of radioembolization and chemotherapy is being explored, this specific approach with Ho-166 is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 % * 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 Exclusion Criteria: * 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 * 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)
Where this trial is running
Leuven, Vlaams-Brabant and 1 other locations
- University Hospital Leuven — Leuven, Vlaams-Brabant, Belgium (Not_yet_recruiting)
- Netherlands Cancer Institute — Amsterdam, Noord Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Elisabeth G Klompenhouwer, MD, PhD
- Email: holibreast@nki.nl
- Phone: +31205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.