Eribulin as 1st Line Treatment in Elderly Patients With Advanced Breast Cancer

Inclusion Criteria:

• Patient must give written informed consent according to ICH/GCP regulations beforeregistration
• Histologically or cytologically confirmed locally advanced or metastatic HER2-neg,hormone receptor positive or negative adenocarcinoma of the breast with measurable orevaluable disease according to RECIST 1.1 criteria
• At least 6 months since last adjuvant/neoadjuvant chemotherapy administration beforeregistration
• At least 2 weeks since prior radiotherapy or endocrine therapy and complete recoveryfrom these interventions at time of registration
• Baseline C-SGA and patient-reported outcome (PRO) forms have been completed
• Female patient at the age of ≥70 years
• WHO performance status 0-2
• Adequate hematological values: hemoglobin ≥80 g/L (transfusions are allowed),neutrophils ≥1.5 x 109/L, platelets ≥ 100 x 109/L
• Adequate hepatic function: bilirubin ≤1.5 x ULN, AST ≤3 x ULN, alkaline phosphatase (AP) ≤2.5 x ULN (in case of liver metastases ≤5 x ULN or in case of bone metastases ≤10 x ULN)
• Adequate renal function (calculated creatinine clearance >40 mL/min, according to theformula of Cockcroft-Gault)

Exclusion Criteria:

• Known CNS metastases
• Previous malignancy within 3 years with the exception of adequately treated cervicalcarcinoma in situ or localized non-melanoma skin cancer
• Prior chemotherapy for advanced disease
• Concurrent anticancer treatment or treatment in a clinical trial within 30 days priorto registration. Exception: participation in SAKK 96/12
• Palliative irradiation prior to study entry with more than 30% of marrow-bearing boneirradiated
• Pre-existing neuropathy ≥G2 (according to CTCAE v4.0) at registration
• Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV (see Appendix 4), unstable angina pectoris, history of myocardial infarction withinthe last three months, significant arrhythmias, congenital long QT-syndrome)
• Any concomitant drugs contraindicated for use with the trial drugs according to theapproved product information
• Known hypersensitivity to trial drug or to any component of the trial drug
• Any serious underlying medical condition (at the judgment of the investigator) whichcould impair the ability of the patient to participate in the trial (e.g. activeautoimmune disease, uncontrolled diabetes)
• Psychiatric disorder precluding understanding of trial information, giving informedconsent, taking part in the geriatric assessment, or interfering with compliance/withthe trial protocol
• Any familial, sociological or geographical condition potentially hampering properstaging and compliance with the trial protocol