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NCT00781612 · ClinicalTrials.gov record · last posted 2026-08-27

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

StatusActive, Not Recruiting
PhasePhase 2
Started2008-10-16
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from the ClinicalTrials.gov record
This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

Protocol amendment history 3 changes detected by DataLookout

2026-08-28
Enrollment reduced: 720 → 378 participants
2026-08-28
Primary completion moved earlier: 2029-09-30 → 2026-10-31
2026-08-28
Completion moved earlier: 2030-04-30 → 2026-11-28
Trial Details
NCT Number NCT00781612
Lead Sponsor Genentech, Inc.
Collaborators: Hoffmann-La Roche
Conditions Neoplasm Metastasis
Enrollment 378 participants
Start Date 2008-10-16
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-11-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-27