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Tucatinib in HER2+ metastatic breast cancer

NCT02614794Phase 2

Key facts

Status: Completed
Start: Jan 2016
Primary completion: Sep 2019
Countries: 15
Sponsor: Seagen Inc.
Modality: Small Molecules

Drugs: tucatinib
Conditions: HER2-positive breast cancer

Overview

Phase 2, randomised, double-blind trial in HER2-positive breast cancer comparing Tucatinib Arm with Placebo Arm (2 arms). Primary endpoint: Progression-free Survival at 34.6 months. Started Jan 2016; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Tucatinib Arm
Tucatinib + Capecitabine + Trastuzumab
Placebo Arm
Placebo + Capecitabine + Trastuzumab

Who it enrols

Patients with HER2+ breast cancer previously treated with trastuzumab, pertuzumab, and T-DM1. Allows patients with brain metastases.

Endpoints

Primary

Progression-free Survival34.6 months

Secondary

Progression-free Survival in Patients With Brain Metastases34.6 months
Overall Survival60.1 months
Objective Response Rate34.6 months
Duration of Response33.2 months
Clinical Benefit Rate34.6 months
Incidence of Adverse Events60.1 months
Ctrough of Tucatinib3.5 months

Results

Primary endpoints met

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