A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer

An Open-label Pilot Study of the Effect of Second-line Treatment With Herceptin Monotherapy on Time to Disease Progression in Patients With Metastatic Urothelial Cancer and HER2 Overexpression

This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.

Inclusion Criteria:

• adult patients >=18 years of age;
• metastatic urothelial cancer;
• disease progression during or after 1 prior platinum-based chemotherapy;
• measurable disease;
• HER2 overexpression (IHC [2+] or [3+]).

Exclusion Criteria:

• concomitant chemotherapy or immunotherapy;
• active or uncontrolled infection;
• solely CNS metastases;
• clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
• co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.