Patients with metastatic breast cancer
Conditions
Interventions
Product Name: Eribulin mesylate
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: ERIBULIN MESYLATE
CAS Number: 441045-17-6
Other descriptive name: ERIBULIN MESYLATE
Concentrat
Sponsors
Azienda Ospedaliera Fatebenefratelli e Oftalmico - Milano, Italy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study: 1.Female patients =18 years 2.Diagnosis of metastatic breast cancer 3.Previous treatment with anthracyclines and taxanes 4.Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication 5.Ability to comply with sample collection 6.Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF. 7.Absence of any contraindication to treatment as in sections “Contraindication” “Special warning” and “Interaction with other medicinal product” of the Summary of product characteristics (SPC). 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from study enrollment: 1.Previous treatment with Eribulin in a previous line of treatment 2.Previous treatment with Eribulin off label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is primarily aimed at surveying the tolerability profile of Eribulin in an unselected population of patients with MBC in relation to toxicities already described in clinical trials, and neurotoxicity in particular. ;Secondary Objective: The secondary objectives of this trial include: •To study the relationship between specific genetic polymorphism and incidence and severity of peripheral neuropathy •To describe treatment efficacy in terms of duration of treatment and impact on survival. ;Primary end point(s): 1.Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade), especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropoenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities. ;Timepoint(s) of evaluation of this end point: During the treatment untill 30 days after treatment discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy -Evaluation of quality of life during treatment using EORTC QLQ-C30 and QLQ-BR23 questionnaires. -Assessment of dose intensity and dose schedule maintenance. -DOT (Duration Of Treatment) and OS (Overall Survival). ;Timepoint(s) of evaluation of this end point: During the treatment, untill 30 days after treatment discontinuation and untill death | — |
Countries
Italy
Contacts
Public ContactNicla La Verde
Azienda Ospedaliera Fatebenefratelli e Oftalmico - Milano, Italy
Outcome results
None listed