Trials / Completed
CompletedNCT01644890
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 436 (actual)
- Sponsor
- Nippon Kayaku Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years – 74 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study is a randomized, open-label, multi-national phase III study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NK105 | IV, Weekly |
| DRUG | Paclitaxel | IV, Weekly |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2016-07-01
- Completion
- 2017-01-01
- First posted
- 2012-07-19
- Last updated
- 2019-07-29
- Results posted
- 2019-07-29
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01644890. Inclusion in this directory is not an endorsement.