Dataset Information

Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study).

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.

SUBMITTER: Quintela-Fandino M

PROVIDER: S-EPMC4453846 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Publications

Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study).

Quintela-Fandino M M Urruticoechea A A Guerra J J Gil M M Gonzalez-Martin A A Marquez R R Hernandez-Agudo E E Rodriguez-Martin C C Gil-Martin M M Bratos R R Escudero M J MJ Vlassak S S Hilberg F F Colomer R R

British journal of cancer 20140724 6

<h4>Introduction</h4>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.<h4>Methods</h4>Her-2-negative breast cancer patients with tumours larger than 2 cm were eligible for dose-escalation trial (classic 3+3 method).<h4>Results</h4>The recommended phase II dose (RP2D) was 150 mg BID of nintedanib combined with standard dose of w ...[more]

PMID: 25058346

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Dataset Information

Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study).

Introduction

Methods

Results

Conclusions

Publications

Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study).

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