At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 436 enrolled
Drug / intervention
NK105 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
In Brief
A Phase 3 clinical trial evaluating NK105 and Paclitaxel for Breast Cancer Nos Metastatic Recurrent. Completed, enrolled 436 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer Nos Metastatic Recurrent
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionJul 2016
Study CompletionJan 2017
TodayJul 2026
First PostedJul 19, 2012
Enrollment StartJul 1, 2012
Primary CompletionJul 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 14.0 years ago
Interventions
NK105drug
IV, Weekly
Paclitaxeldrug
IV, Weekly