A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression

An Open-label Pilot Study of Herceptin Monotherapy on Objective Treatment Response in Patients With Metastatic or Locally Advanced Gastric Cancer Who Had Disease Progression During Platinum-based or 5-fluoropyrimidine-based Chemotherapy

This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.

Inclusion Criteria:

• adult patients 18-75 years of age;
• metastatic or advanced gastric cancer;
• disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
• >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
• >=1 measurable lesion;
• HER2 overexpression (IHC [2+] or [3+]).

Exclusion Criteria:

• concurrent chemotherapy or immunotherapy;
• brain or meningeal metastases;
• clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
• co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
• women who are pregnant or breastfeeding.