A Phase III Study of NK105 in Patients With Breast Cancer
A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
1 other identifier
interventional
436
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2012
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 17, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
July 29, 2019
CompletedJuly 29, 2019
February 1, 2016
4 years
July 17, 2012
May 26, 2019
May 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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 Outcomes (2)
Overall Survival
Baseline, every 6 weeks of study treatment period, and end of study.
Overall Response Rate
Baseline, every 6 weeks of study treatment period, and end of study.
Study Arms (2)
NK105
EXPERIMENTALPaclitaxel
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Japan Sites
Tokyo, Etc., Japan
Related Publications (1)
Fujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12.
PMID: 30745582DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No limitation
Results Point of Contact
- Title
- Pharmaceuticals Group
- Organization
- Nippon Kayaku Co., Ltd.
Study Officials
- STUDY DIRECTOR
Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time)
Nippon Kayaku Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2012
First Posted
July 19, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2016
Study Completion
January 1, 2017
Last Updated
July 29, 2019
Results First Posted
July 29, 2019
Record last verified: 2016-02