A Phase III Study of NK105 in Patients With Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer Nos Metastatic Recurrent
• Interventions: Drug: NK105; Drug: Paclitaxel

• Registration Number: NCT01644890
• Lead Sponsor: Nippon Kayaku Co., Ltd.

Brief 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.

Detailed Description

This study is a randomized, open-label, multi-national phase III study.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-19
• Status Verified: 2016-02
• Primary Completion: 2016-07
• Study Completion: 2017-01
• Results First Submitted: 2019-05-26
• Results First Submitted QC: 2019-05-26
• Last Update Submitted: 2019-05-26
• Results First Posted: 2019-07-29
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 436

Inclusion Criteria

• Written informed consent of the patient signed by herself.
• Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
• Aged 20 to 74 at the time of informed consent.

Exclusion Criteria

• Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NK105	NK105	-
Paclitaxel	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Baseline, every 6 weeks of study treatment period, and end of study,	PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.; Assessment period was from the day of randomisation until the first observation of lesion progression or death

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Baseline, every 6 weeks of study treatment period, and end of study.	OS is defined as the period from the day of randomization until the day of death from any cause.; Assessment period was from the day of randomisation until the first observation of lesion progression or death
Overall Response Rate	Baseline, every 6 weeks of study treatment period, and end of study.	ORR is the proportion of patients who are assessed as complete response or partial response as the best overall response among evaluable patients, according to RECIST Ver.1.1.; Assessment period was from the day of randomisation until the first observation of lesion progression or death

Trial Locations

Locations (1)

Japan Sites; 🇯🇵 Tokyo, Etc., Japan