Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)

Summary

Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel and was selected for development based on a better antiproliferative activity on resistant cell lines than docetaxel. It has shown superior survival against mitoxantrone (MTX) plus prednisone in docetaxel pre-treated hormone refractory metastatic prostate cancer patients leading to registration of the compound. It showed a favorable toxicity profile with an interestingly low rate of alopecia. In the Genevieve study it will be compared against weekly paclitaxel which is currently most widely used treatment of breast cancer patients. A head-to-head comparison in the neoadjuvant setting will allow a rapid and precise comparison of efficacy and tolerability of cabacitaxel versus paclitaxel to decide in how far further development of this taxoid in breast cancer is reasonable.

Timeline

Start

2013-02

Primary completion

2015-08

Completion

2016-02

Publications

• Results Kummel S, Paepke S, Huober J, Schem C, Untch M, Blohmer JU, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Jackisch C, Schneeweiss A, Denkert C, Engels K, Klare P, Fasching PA, von Minckwitz G, Burchardi N, Loibl S. Randomised, open-label, phase II study comparing the efficacy and the safety of cabazitaxel versus weekly paclitaxel given as neoadjuvant treatment in patients with operable triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE). Eur J Cancer. 2017 Oct;84:1-8. doi: 10.1016/j.ejca.2017.06.037. Epub 2017 Jul 30.

Drugs

Indications