A Phase III Study of NK105 in Patients With Breast Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
First received: July 17, 2012
Last updated: April 13, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Breast Cancer Nos Metastatic Recurrent
Drug: NK105
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer

Resource links provided by NLM:

Further study details as provided by Nippon Kayaku Co.,Ltd.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 4.2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 414
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NK105 Drug: NK105
IV, Weekly
Active Comparator: Paclitaxel Drug: Paclitaxel
IV, Weekly

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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01644890

Japan Sites
Tokyo, etc., Japan
Sponsors and Collaborators
Nippon Kayaku Co.,Ltd.
Study Director: Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time) Nippon Kayaku Co.,Ltd.
  More Information

Responsible Party: Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01644890     History of Changes
Other Study ID Numbers: A3105301 
Study First Received: July 17, 2012
Last Updated: April 13, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nippon Kayaku Co.,Ltd.:
NK105, Paclitaxel, Breast cancer, Micelle

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Albumin-Bound Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 25, 2016