Dataset Information

A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.

ABSTRACT:

Background

NK105 is a novel nanoparticle drug delivery formulation that encapsulates paclitaxel (PTX) in polymeric micelles. We conducted an open-label phase III non-inferiority trial to compare the efficacy and safety of NK105 and PTX in metastatic or recurrent breast cancer.

Methods

Patients were randomly assigned in a 1:1 ratio to receive either NK105 (65 mg/m²) or PTX (80 mg/m²) on days 1, 8 and 15 of a 28-day cycle. The primary endpoint was progression-free survival (PFS), with a non-inferiority margin of 1.215.

Results

A total of 436 patients were randomised and 211 patients in each group were included in the efficacy analysis. The median PFS was 8.4 and 8.5 months for NK105 and PTX, respectively (adjusted hazard ratio: 1.255; 95% confidence interval: 0.989-1.592). The median overall survival and overall response rates were 31.2 vs. 36.2 months and 31.6% vs. 39.0%, respectively. The two groups exhibited similar safety profiles. The incidence of peripheral sensory neuropathy (PSN) was 1.4% vs. 7.5% (≥Grade 3) for NK105 and PTX, respectively. The patient-reported outcomes of PSN were significantly favourable for NK105 (P < 0.0001).

Conclusions

The primary endpoint was not met, but NK105 had a better PSN toxicity profile than PTX.

Clinical trial registration

ClinicalTrials.gov: NCT01644890.

SUBMITTER: Fujiwara Y

PROVIDER: S-EPMC6461876 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.

Fujiwara Yasuhiro Y Mukai Hirofumi H Saeki Toshiaki T Ro Jungsil J Lin Yung-Chang YC Nagai Shigenori E SE Lee Keun Seok KS Watanabe Junichiro J Ohtani Shoichiro S Kim Sung Bae SB Kuroi Katsumasa K Tsugawa Koichiro K Tokuda Yutaka Y Iwata Hiroji H Park Yeon Hee YH Yang Youngsen Y Nambu Yoshihiro Y

British journal of cancer 20190212 5

<h4>Background</h4>NK105 is a novel nanoparticle drug delivery formulation that encapsulates paclitaxel (PTX) in polymeric micelles. We conducted an open-label phase III non-inferiority trial to compare the efficacy and safety of NK105 and PTX in metastatic or recurrent breast cancer.<h4>Methods</h4>Patients were randomly assigned in a 1:1 ratio to receive either NK105 (65 mg/m<sup>2</sup>) or PTX (80 mg/m<sup>2</sup>) on days 1, 8 and 15 of a 28-day cycle. The primary endpoint was progression-f ...[more]

PMID: 30745582

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Dataset Information

A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients.

Similar Datasets

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