A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer

A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors

This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.

Inclusion Criteria:

• Ongoing participants from any completed global Roche-sponsored Herceptin trial
• Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable disease (or whose disease has not recurred) during Herceptin therapy at the end of the lead-in trial
• Available study termination data (including tumor assessment and laboratory data) on the Case Report Form for the lead-in trial
• Judged eligible by the investigator following a thorough risk/benefit assessment, if signs of chronic heart failure developed during the lead-in trial

Exclusion Criteria:

• Pregnant or nursing women
• Women of childbearing potential unless using effective contraception as determined by the investigator
• Severe dyspnea at rest requiring supplementary oxygen therapy
• Severe uncontrolled systemic disease