Skip to main content
OpenTrials
Completed

NCT Number: NCT01644890

A Phase III Study of NK105 in Patients With Breast Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Nos Metastatic Recurrent Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Japan Sites

Tokyo, Etc., Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NK105

Drug

IV, Weekly

paclitaxel

Drug

IV, Weekly

Primary outcomes

  1. Progression Free Survival

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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

  2. Overall Response Rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nippon Kayaku Co., Ltd.

Industry

Registry information

Official study title

A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jul 19, 2012
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.