Trial intelligence / Profile preview

Ertumaxomab in HER2-low Advanced Breast Cancer

NCT00452140Phase 2

Key facts

Status
Terminated
Start
Mar 2007
Countries
5
Modality
Antibody Conjugates, Bispecific Antibodies, Monoclonal Antibodies
Conditions
breast cancer
01

Overview

Phase 2, open-label, single-arm trial of ertumaxomab in breast cancer, sponsored by Neovii Pharmaceuticals. Primary endpoint: Objective Response Rate. Started Mar 2007; status: terminated.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Ertumaxomab

    Ertumaxomab 10 µg (day 0) then 100 µg weekly

03

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Clinical Benefit Rate

  • Duration of Response

  • Time to Progression

  • Adverse Events

  • Human Anti-Murine Antibodies

  • Vital Signs

  • Laboratory Parameters

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