Access : Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010|[sol]|GEICAM-2010-10 study) : British Journal of Cancer

Access : Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010|[sol]|GEICAM-2010-10 study) : British Journal of Cancer

Short Communication

British Journal of Cancer 111, 1060-1064 (09 September 2014) | doi:10.1038/bjc.2014.397

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  • M Quintela-Fandino
  • A Urruticoechea
  • J Guerra
  • M Gil
  • A Gonzalez-Martin
  • R Marquez
  • more authors of this article

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

Abstract

Introduction:

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.

Methods:

Her-2-negative breast cancer patients with tumours larger than 2 cm were eligible for dose-escalation trial (classic 3+3 method).

Results:

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%.

Conclusions:

The combination allows the delivery of full-dose intensity, while efficacy seems promising.