Trial intelligence / Profile preview

Tanespimycin + Trastuzumab in Advanced Breast Cancer

NCT00773344Phase 2

Key facts

Status: Completed
Start: Dec 2005
Primary completion: May 2009
Countries: 1
Sponsor: Bristol Myers Squibb
Modality: Small Molecules

Drugs: tanespimycin
Conditions: breast cancer

Overview

Phase 2, open-label, single-arm trial of tanespimycin in breast cancer, sponsored by Bristol Myers Squibb. Primary endpoint: Objective Tumor Response Rate. Started Dec 2005; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Tanespimycin + Trastuzumab
Tanespimycin IV weekly + Trastuzumab IV weekly

Who it enrols

Adult patients with metastatic HER2-positive breast cancer (or solid tumors in Phase 1) who have progressed on prior trastuzumab therapy, with adequate organ function and performance status.

Endpoints

Primary

Objective Tumor Response RateEvery 8 weeks

Secondary

Duration of Response12 months
Time to Progression12 months
Progression-Free Survival12 months
Overall Survival12 months

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