HER2-negative breast cancer with brain metastases MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: HALAVEN
Product Name: Halaven
Pharmaceutical Form: Solution for injection/infusion
CAS Number: 253128-41-5
Other descriptive name: ERIBULIN
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Institut Paoli-Calmettes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age. 2. Life expectancy of 3 months or longer. 3. ECOG performance status of 0, 1, or 2. 4. HER2-negative (IHC 0/1+ or 2+ and in situ hybridization negative) metastatic breast cancer 5. Locally advanced or metastatic breast cancer that have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless pa-tients were not suitable for these treatments. (no limit to the number of previous lines of therapy, no need for extracranial disease) 6. At least 2 weeks washout period post chemotherapy, targeted or biologic therapy, or radiation therapy is required prior to study entry 7. Patient with untreated CNS disease or previous SRS/surgery without WBRT (cohorts A and B) - At least 1 measurable CNS lesion = 10 mm on T1-weighted gadolinium-enhanced MRI, OR - At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two addi-tional CNS tumors measuring = 3 mm in longest diameter, for which the sum of the longest diameters is = 10 mm. 8. Patient with progressive disease harboring brain metastases after previous WBRT (cohort C) - At least 1 measurable CNS lesion = 10 mm on T1-weighted gadolinium-enhanced MRI, OR - At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two addi-tional CNS tumors measuring = 3 mm in longest diameter, for which the sum of the longest diameters is = 10 mm. 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Prior therapy with eribulin. 2. Patients should not have had major surgery or radiotherapy (therapeutic and/or pallia-tive) within 14 days prior to initiation of study treatment, including CNS-directed radia-tion therapy. (Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of eribulin for treatment of HER2-negative BCBM ;Secondary Objective: -To assess the safety of Eribulin in this population. -Time to WBRT (cohort A and B) -CNS progression-free survival -Overall survival -To assess the change in cognitive function -Quality of life ;Primary end point(s): Eribulin efficacy will be assessed by estimating CNS objective response rate per RANO-BM criteria. CNS objective response rate will be defined as the rate of patients with a partial response or a complete response as defined by RANO-BM criteria. Brain MRI will be performed at inclusion and every 6 weeks thereafter during the treatment phase to allow CNS disease assessment according to RANO-BM criteria. CNS disease will be evaluated centrally by trained radiologists and response status will be defined according both radiological and clinical (including steroids use and clinical status) assessments. Tumor response will be confirmed by a second examination performed at least 4 weeks after the criteria for response will be met. ;Timepoint(s) of evaluation of this end point: Brain MRI will be performed at inclusion and every 6 weeks thereafter during the treatment phase to allow CNS disease assessment according to RANO-BM criteria. Tumor response will be confirmed by a second examination performed at least 4 weeks after the criteria for response will be met. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Toxicity will be evaluated before every chemotherapy infusion according to NCI CTCAE v5.0 criteria. All treatment-related adverse events will be collected. The rate of grade 3 to 5 adverse events will be analyzed. - Time to WBRT will be defined as the time from Eribulin initiation to WBRT start. - CNS progression-free survival will be defined as the time from Eribulin initiation to CNS disease progression according to RANO-BM criteria or death from any cause. - Overall survival will be defined as the time from Eribulin initiation to death from any cause. - Cognitive function will be evaluated by self-report Fact-Cog v3.0 questionnaires that will have to be filled every two cycles (before every day 1 infusion). - Quality of life will be measured by Functional Assessment of Cancer Therapy-Brain Metastasis (FACT-Br v4.0) questionnaire. This questionnaire will be filled every two cycles. ;Timepoint(s) of evaluation of this end point: Toxicity and time to WBRT: the time from Eribulin initiation to WBRT start CNS progression-free survival: the time from Eribulin initiation to CNS disease progression according to RANO-BM criteria or death from any cause overall survival: the time from Eribulin initiation to death from any cause Fact-Cog and Fact-Br: every two cycles | — |
Countries
France
Contacts
Public ContactProject manager
Institut Paoli-Calmettes
Outcome results
None listed