At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 112 enrolled
Drug / intervention
Trastuzumab emtansine [Kadcyla]drug
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 II, Single-arm, Open-label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy
In Brief
A Phase 2 clinical trial evaluating Trastuzumab emtansine [Kadcyla] for Metastatic Breast Cancer. Completed, enrolled 112 participants across 40 sites.
Detailed Summary
This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedJul 2007
Primary CompletionJan 2009
Study CompletionJun 2009
TodayJul 2026
First PostedJul 31, 2007
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.9 years ago
Interventions
Trastuzumab emtansine [Kadcyla]drug
Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.