A Phase III Study of NK105 in Patients With Breast Cancer

May 26, 2019 updated by: Nippon Kayaku Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

436

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Etc., Japan
        • Japan Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paclitaxel
Drug: Paclitaxel
IV, Weekly
Experimental: NK105
Drug: NK105
IV, Weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, every 6 weeks of study treatment period, and end of study,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, every 6 weeks of study treatment period, and end of study.
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
Baseline, every 6 weeks of study treatment period, and end of study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nippon Kayaku Co., Ltd.

Investigators

  • Study Director: Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time), Nippon Kayaku Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (Estimate)

July 19, 2012

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

May 26, 2019

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3105301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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