EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer

Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy (e.g. known congestive cardiac failure).
* Measurable disease or non-measurable but evaluable disease according to RECIST 1.1 criteria
* ECOG performance status 0-2
* Estimated life expectancy of ≥ 12 weeks
* No known active/symptomatic CNS metastases
* No previous chemotherapy for breast cancer in the advanced setting
* Adequate organ function including ( Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5 x 10\^9/L; Platelets ≥ 100 x 10\^9/L; Bilirubin ≤ 1.5 mg/dL; ALT and AST ≤ 3 x ULN (with or without known hepatic metastases); ALP ≤ 2.5 x ULN; Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance (CrCl) ≥ 50mL/min according to the Cockcroft Gault formula
* Written informed consent (according to ICH/GCP and national/local regulations)

Exclusion Criteria:

* Significant peripheral neuropathy (significant peripheral neuropathy is defined as ≥ grade 2 on CTCAE v4.0 criteria)
* Clinically significant comorbidities including: uncontrolled cardiac arrhythmias (except rate-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
* Other malignancy within the last 5 years, except for adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ
* Intake of any concomitant medications or therapies that may potentially interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry
* Presence of any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before trial registration