The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes.
Patients will be screened with the Ixabepilone DRP. If the tumor tissue has a DRP( Drug Response Prediction) score of \>67% (Belgium \>33%) the patient can be included in the clinical study. Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
Onze-Lieve-Vrouwziekenhuis
Aalst, Aalst, Belgium
Antwerp University Hospital
Antwerp, Edegem, Belgium
Clinical Benefit Rate (CBR)
To evaluate the clinical benefit rate of ixabepilone using tumor measurements (e.g. CT or MRI etc.). One-sided comparisons of CBR between treatment and historic control will be performed, and will be repeated for subgroups defined by ER status.
Time frame: Baseline to 24 weeks
Progression Free Survival (PFS)
PFS defined as time from inclusion until progressive disease(PD) according to RECIST v 1.0 or death of any reason
Time frame: 1 year
Overall Survival (OS)
OS defined as time from inclusion until death
Time frame: 1 year
Overall Response Rate (ORR) Defined as CR + PR
Objective response rate (ORR) as defined as complete response (CR) + partial response (PR) according to RECIST v 1.0
Time frame: 1 year
Incidence of Treatment-Emergent Adverse Events Measured by NCI-CTCAE v.5.0
A description of the extent, duration and reversibility of ixabepilone elicited toxicity in target organs based on the Common Terminology Criteria for Adverse Events (NCI-CTCAE v.5.0)
Time frame: 1 year
Clinical Benefit Rate (CBR) - Fresh Biopsy Versus Archival
Assess difference in prediction based on archival and fresh biopsy from same patient (percent agreement in binary prediction, and difference in primary and secondary endpoints with archival versus fresh biopsies)
Time frame: 1 year
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Clin. Univ. Saint-Luc
Brussels, Belgium
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Liège, Belgium
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Berlin, Germany
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Modena, Italy
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