Trial of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in HER2-negative Breast Cancer

Summary

The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. This is a prospective single-center study that will investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant chemotherapy).

Timeline

Start

2011-11

Primary completion

2012-09

Completion

2012-11

Outcome

Met primary endpoint

paper The mean % reduction in MRI estimated tumor volume at the end of EndoTAG-1 plus paclitaxel treatment was 81% (95% CI, 66% to 96%, p<0.001) PMID 27454930 ↗

Publications

• Ignatiadis M, Zardavas D, Lemort M, Wilke C, Vanderbeeken MC, D'Hondt V, De Azambuja E, Gombos A, Lebrun F, Dal Lago L, Bustin F, Maetens M, Ameye L, Veys I, Michiels S, Paesmans M, Larsimont D, Sotiriou C, Nogaret JM, Piccart M, Awada A. Feasibility Study of EndoTAG-1, a Tumor Endothelial Targeting Agent, in Combination with Paclitaxel followed by FEC as Induction Therapy in HER2-Negative Breast Cancer. PLoS One. 2016 Jul 25;11(7):e0154009. doi: 10.1371/journal.pone.0154009. eCollection 2016.

Drugs

Indications