To evaluate the efficacy of eribulin for treatment of HER2-negative breast cancer brain metastases (BCBM)
This study will explore eribulin in three specific cohorts of patients with HER2-negative metastatic breast cancer harboring BCBM, pretreated with anthracyclines and taxanes: * Cohort A = Newly diagnosed, untreated BCBM, not candidate to initial surgery or stereotactic radiosurgery (SRS) and with pauci-symptomatic disease not requiring immediate whole-brain radiation therapy (WBRT) * Cohort B = BCBM pretreated with SRS and/or surgery alone, without WBRT, and not requiring immediate WBRT * Cohort C = BCBM pretreated with WBRT
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Patients will receive eribulin 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Institut de Cancerologie de L'Ouest - Paul Papin
Angers, France
Institut Sainte Catherine
Avignon, France
CHU Besançon
Besançon, France
Institut Paoli-Calmettes
Marseille, France
Efficacy of eribulin for treatment of HER2-negative BCBM
By estimating central nervous system (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 (Lin et al. 2015)
Time frame: from inclusion until 30 days after completion of treatment
Safety of Eribulin in this population
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 frame: from Eribulin initiation until 30 days after completion of treatment
Time to WBRT (cohort A and B)
Time to WBRT will be defined as the time from Eribulin initiation to WBRT start
Time frame: from Eribulin initiation to the time of the first dose of whole brain radiation therapy - up to 28 months
CNS progression-free survival
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
Time frame: from Eribulin initiation until the date of first documented CNS disease progression or date of death from any cause - up to 28 months
Overall survival
Overall survival will be defined as the time from Eribulin initiation to death from any cause
Time frame: from Eribulin initiation to death
Change in cognitive function
Cognitive function will be evaluated by self-report Fact-Cog v3.0 questionnaires (French validated version;(Joly et al. 2012)) that will have to be filled every two cycles (before every day 1 infusion)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Institut Du Cancer de Montpellier
Montpellier, France
Institut De Cancérologie de l'Ouest
Saint-Herblain, France
Institut de Cancerologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, France
Time frame: From Eribulin initiation up to 7 days after study treatment discontinuation
Quality of life measured by Functional Assessment of Cancer Therapy-Brain Metastasis
Quality of life will be measured by Functional Assessment of Cancer Therapy-Brain Metastasis (FACT-Br v4.0, (Thavarajah et al. 2014)) questionnaire. This questionnaire will be filled every two cycles
Time frame: From Eribulin initiation up to 7 days after study treatment discontinuation