Trial Profile

Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 07 Apr 2026

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At a glance

Drugs Doxorubicin liposomal (Primary) ; Tucatinib (Primary)
Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
Focus Therapeutic Use
Sponsors SCRI Development Innovations

Most Recent Events

20 Mar 2026 Planned End Date changed from 1 Jul 2026 to 1 Nov 2027.
20 Mar 2026 Planned primary completion date changed from 1 Jul 2026 to 1 Nov 2027.
10 Nov 2025 According to Ontada media release, Ontada will present Framework for Accelerating Clinical Development with Real-World External Control Arms in Phase 2 Trials in an oral presentation at the ISPOR Europe 2025 conference, being held this week in Glasgow, Scotland.

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