Prospective, monocentre phase I study of sequential infusion of Y90-labeled microspheres and Mitomycine C in patients with chemorefractory liver metastases from breast carcinoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000454-58-BE

Enrollment

Registered

2012-03-22

Start date

2012-04-18

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chemorefractory liver metastases from breast carcinoma

Interventions

Trade Name: Mitomycin-C Kyowa 2 mg, poeder voor injectievloeistof Mitomycin-C Kyowa 15 mg, poeder voor injectievloeistof Mitomycin-C Kyowa 40 mg, poeder voor injectievloeistof Pharmaceutical Form: Pow

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically confirmed diagnosis of breast cancer Radiological evidence of liver metastases Liver-only or liver predominant disease Progressive under (multi-line) systemic chemotherapy Progressive under hormonotherapy for hor+ patients. Patients scheduled for mitomycine chemoinfusion Liver/lung shunt =70 Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: . Karnovsky 1.5; AST/ALT > 2.5 fold normal range; Creatinine > 1.2 upper normal limit; GFR (glomerular filtration rate) 20% as determined by the Tc99-scan . Allergy to contrast media . Intake of oral anticoagulation

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Assessment of systemic toxicity according to the CTC4.0 criteria (http://ctep.info.nih.gov/reporting/ctc.html) 2. Partial response: Changes in tumor volume (RECIST-criteria) and vascularisation/tumor necrosis before versus after chemo-embolization, analysed by MR imaging including perfusion and diffusion-weighted imaging, as a surrogate for survival 3. Time to progression in the liver;Secondary Objective: 1. Correlation of perfusion and diffusion weighted images and assessment of the value of diffusion imaging in predicting outcome of transarterial Y90 infusion followed by transarterial MMC chemoinfusion for liver metastases. 2. Overall survival;Primary end point(s): 1. Assessment of systemic toxicity according to the CTC4.0 criteria (http://ctep.info.nih.gov/reporting/ctc.html) 2. Partial response: Changes in tumor volume (RECIST-criteria) and vascularisation/tumor necrosis before versus after chemo-embolization, analysed by MR imaging including perfusion and diffusion-weighted imaging, as a surrogate for survival 3. Time to progression in the liver ;Timepoint(s) of evaluation of this end point: week -2 week 1 week 6-10 week 14 week 18 week 22-26-30	—

Measure

Time frame

Main Objective: 1. Assessment of systemic toxicity according to the CTC4.0 criteria (http://ctep.info.nih.gov/reporting/ctc.html) 2. Partial response: Changes in tumor volume (RECIST-criteria) and vascularisation/tumor necrosis before versus after chemo-embolization, analysed by MR imaging including perfusion and diffusion-weighted imaging, as a surrogate for survival 3. Time to progression in the liver;Secondary Objective: 1. Correlation of perfusion and diffusion weighted images and assessment of the value of diffusion imaging in predicting outcome of transarterial Y90 infusion followed by transarterial MMC chemoinfusion for liver metastases. 2. Overall survival;Primary end point(s): 1. Assessment of systemic toxicity according to the CTC4.0 criteria (http://ctep.info.nih.gov/reporting/ctc.html) 2. Partial response: Changes in tumor volume (RECIST-criteria) and vascularisation/tumor necrosis before versus after chemo-embolization, analysed by MR imaging including perfusion and diffusion-weighted imaging, as a surrogate for survival 3. Time to progression in the liver ;Timepoint(s) of evaluation of this end point: week -2 week 1 week 6-10 week 14 week 18 week 22-26-30

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Correlation of perfusion and diffusion weighted images and assessment of the value of diffusion imaging in predicting outcome of transarterial Y90 infusion followed by transarterial MMC chemoinfusion for liver metastases. 2. Overall survival;Timepoint(s) of evaluation of this end point: week -2 week 1 week 6-10 week 14 week 18 week 22-26-30	—

Countries

Belgium

Contacts

Public ContactUZ Leuven

University Hospitals Leuven

geert.maleux@uzleuven.be3216343782

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026