British Journal of Cancer 111, 1060-1064 (09 September 2014) | doi:10.1038/bjc.2014.397
Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
M Quintela-Fandino, A Urruticoechea, J Guerra, M Gil, A Gonzalez-Martin, R Marquez, E Hernandez-Agudo, C Rodriguez-Martin, M Gil-Martin, R Bratos,M J Escudero, S Vlassak, F Hilberg and R Colomer
Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer. We present a phase I trial of a novel selective agent, nintedanib, plus standard chemotherapy in early breast cancer.
Her-2-negative breast cancer patients with tumours larger than 2 cm were eligible for dose-escalation trial (classic 3+3 method).
The recommended phase II dose (RP2D) was 150 mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide. The dose-limiting toxicity was transaminase elevation. At the RP2D, the dose intensity was ~100%. The pathologic complete response was 50%.
The combination allows the delivery of full-dose intensity, while efficacy seems promising.