INTRODUCTION: Single-agent oral vinorelbine is a standard of care for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) that has progressed on endocrine therapy. Metronomic administration may offer a better balance of efficacy and safety than standard regimens, but data from previous trials are scarce. METHODS: In this open-label, multicenter, phase II trial, patients were randomized to oral vinorelbine administered on a metronomic (50 mg three times weekly) or weekly (60 mg/m2 in cycle 1, increasing to 80 mg/m2 if well tolerated) schedule. Treatment was continued until disease progression or intolerance. The primary endpoint was disease control rate (DCR, the proportion of patients with a best overall confirmed response of CR, PR, or stable disease lasting 6 months or more). RESULTS: One-hundred sixty-three patients were randomized and treated. The DCR was 63.4% (95% confidence interval [CI]: 52.0-73.8) with metronomic vinorelbine and 72.8% (95% CI: 61.8-82.1) with weekly vinorelbine. Weekly vinorelbine was also associated with longer progression-free survival (5.6 vs 4.0 months) and overall survival (26.7 vs 22.3 months) than metronomic vinorelbine, but was associated with more adverse events. CONCLUSIONS: In this randomized phase II trial, single-agent metronomic oral vinorelbine was effective and well tolerated as first-line chemotherapy for patients with HR-positive/HER2-negative ABC. Formal comparisons are not done in this phase II study and one can simply observe that confidence intervals of all endpoints overlap. When deciding for a chemotherapy after failure of endocrine therapy and CDK 4/6 inhibitors, oral vinorelbine might be an option to be given with either schedule. CLINICAL TRIAL REGISTRATION NUMBER: EudraCT 2014-003860-19.

Department of Obstetrics and Gynecology Klinikum Rechts der Isar Technische Universität München Ismaninger Straße 22 81675 Munich Germany

Department of Obstetrics and Gynecology Medical University of Graz Auenbruggerplatz 15 8036 Graz Austria

Hematology and Oncology Department AOU Policlinico di Modena Via del Pozzo 71 41125 Modena Italy

Medical Oncology Department Institut de Cancérologie des HCL 165 chemin du Grand Revoyet 69495 Pierre Bénite and Université de Lyon Lyon France

Medical Oncology University of Milano Bicocca Piazza dell'Ateneo Nuovo 1 20126 Milan Italy

Oncology Department Centre Jean Bernard 9 rue Beauverger 72015 Le Mans France

Oncology Department Centrum Onkologii Ziemi Lubelskiej Ul Jaczewskiego 7 20 090 Lublin Poland

Oncology Department Centrum Terapii Wspolczesnej Ul Kopcinskiego 21 90 242 Łódź Poland

Oncology Department Hospital Clinic i Provincial de Barcelona 170 Esc 2 pl 5 08036 Barcelona Spain

Oncology Department Hospital Juan Ramón Jiménez C Ronda Norte s n 21005 Huelva Spain

Oncology Department Hospital Universitario Arnau De Vilanova Avenida Alcalde Rovira Roure 80 25198 Lleida Spain

Oncology Department Hospital Universitario Ramón y Cajal Carretera De Colmenar Viejo km 9 1 28034 Madrid Spain

Oncology Department Instituto Portugues de Oncologia do Porto Francisco Gentil EPE Rua Dr António Bernardino de Almeida 4200 072 Porto Portugal

Oncology Department Masakikuv Oncologicky Ustav Zluty Kopek 7 656 53 Brno Czech Republic

Oncology Department Petz Aladár County Hospital Vasvári Pál u 2 4 9024 Győr Hungary

Oncology Department SC Oncolab SRL Str Bujorului Nr 7 200385 Craiova Romania

Phase 1 Clinical Research Unit ASST Monza via Pergolesi 33 20052 Monza Italy

Pierre Fabre Medicament Medical and Patient Consumer Department 33 Av Emile Zola 92100 Boulogne Billancourt France

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