The Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
University Hospital Leuven
NOT_YET_RECRUITING
Leuven
Netherlands
Netherlands Cancer Institute
RECRUITING
Amsterdam
Contact Information
Primary
Elisabeth G Klompenhouwer, MD, PhD
holibreast@nki.nl
+31205129111
Time Frame
Start Date: 2023-10-19
Estimated Completion Date: 2026-01-19
Participants
Target number of participants: 13
Treatments
Experimental: Ho-166 radioembolization
Patients will undergo standard procedures for holmium radioembolization
Related Therapeutic Areas
Sponsors
Leads: The Netherlands Cancer Institute
Collaborators: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov