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Breast cancer is a heterogeneous disease. Hormonal blockade is the cornerstone of clinical management of the hormone-positive subtype; however, various mechanisms of resistance arise. One powerful mechanism of resistance is FGFR1 amplification. So far, pilot trials with in the advanced disease setting with FGFR1 inhibitors in breast cancer have yielded confounding results. FGFR1 amplification has been linked to hormonal resistance and increased relapse-rate after loco-regional treatment. With the current available data, there is high uncertainty regarding whether a large and expensive clinical trial in the adjuvant setting should be conducted. This review focuses on the positive and negative aspects of phase 0 clinical trials in order to make expedite go/no-go decisions for drug candidates in this area of research based on pharmacodynamic and pharmacokinetic parameters. We describe the key dose-escalation, pharmacodynamic and pharmacokinetic design aspects of the CNIO-BR-007 phase 0 trial, which combines the multikinase inhibitor nintedanib (a tyrosine-kinase inhibitor against VEGFR1-3, FGFR1-3 and PDGFR) with letrozole, a trial that aims to reach a definitive answer regarding whether or not nintedanib deserves testing in a large, randomized clinical trial in the adjuvant setting. *Correspondence to: Miguel Quintela-Fandino, Breast Cancer Clinical Research Unit, CNIO Spanish National Cancer Research Centre, Melchor Fernandez Almagro, 3 Madrid, 28029, Spain, Tel: 34 917 328 000, Fax: +34 917 328 010, E-mail: mquintela@cnio.es

Nintedanib plus hormonal blockade in early breast cancer: Gathering proof of FGFR1 blockade taking advantage of a phase 0/1 design