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A Phase III Study of NK105 in Patients With Breast Cancer

NCT01644890 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2019-07-29

Study results available
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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.

Conditions

  • Breast Cancer Nos Metastatic Recurrent

Interventions

DRUG

NK105

IV, Weekly

DRUG

Paclitaxel

IV, Weekly

Sponsors & Collaborators

  • Nippon Kayaku Co., Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-07-31
Completion
2017-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644890 on ClinicalTrials.gov