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A Phase III Study of NK105 in Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01644890
Recruitment Status : Completed
First Posted : July 19, 2012
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Nos Metastatic Recurrent Drug: NK105 Drug: Paclitaxel Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: NK105 Drug: NK105
IV, Weekly

Active Comparator: Paclitaxel Drug: Paclitaxel
IV, Weekly

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 4.2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01644890

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nippon Kayaku Co., Ltd. Identifier: NCT01644890     History of Changes
Other Study ID Numbers: A3105301
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2016

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

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