Study design
toxicity
DISEASE
Patients were randomized between oral vinorelbine metronomic three times a week (Mondays, Wednesdays, Fridays or Thursdays, Tuesdays, Saturdays) at 50 mg per day in combination with non-steroidal aromatase inhibitor, letrozole 2,5 mg every day or anastrozole 1 mg every day (Arm B) and oral vinorelbine alone (Arm A). Treatments were taken orally until progression of disease or toxicity. Dose adjustment of oral vinorelbine was possible in case of toxicity. Primary outcome measure was progression-free survival (PFS) evaluated every 8 weeks. Secondary outcome measures were evaluation of partial and complete response rate by RECIST 1.1, duration of response, clinical benefit after 24 weeks of treatment, overall survival, toxicity according to criteria NCI CTAEv4.03 evaluated every 4 weeks and health-related quality of life evaluated every 8 weeks with EORTC QLQ-C30 questionnaire.