A Phase III Study of NK105 in Patients With Breast Cancer

Summary

To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.

Timeline

Start

2012-07

Primary completion

2016-07

Completion

2017-01

Outcome

Missed primary endpoint

paper CONCLUSIONS: The primary endpoint was not met, but NK105 had a better PSN toxicity profile than PTX. PMID 30745582 ↗

Publications

• Fujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12.

Drugs

Indications