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

Roche

Status and phase: Completed; Phase 3

Conditions: Neoplasms

Treatments: Drug: Herceptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02721641

BO15943

2007-000348-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Herceptin

Experimental group

Description:

Participants with stable disease and HER2-overexpressing metastatic or locally advanced cancer will receive expanded access to IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment.

Treatment:

Drug: Herceptin