At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 178 enrolled
Drug / intervention
NKTR-102 +7 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 Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
In Brief
A Phase 3 clinical trial evaluating NKTR-102, Eribulin, and 6 other interventions for Metastasis and Breast Cancer. Completed, enrolled 178 participants across 56 sites in 10 countries.
Detailed Summary
This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastasis, Breast Cancer
CountriesAustralia, Belgium, Canada, France, Israel, Italy, Portugal, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartNov 2016
Primary CompletionJul 2020
TodayJul 2026
First PostedSep 27, 2016
Enrollment StartNov 1, 2016
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.8 years ago
Interventions
NKTR-102drug
Eribulindrug
Ixabepilonedrug
Vinorelbinedrug
Gemcitabinedrug
Paclitaxeldrug
Docetaxeldrug
Nab-paclitaxeldrug