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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Herceptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herceptin<br>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. | Drug: Herceptin<br>* Herceptin will be administered as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.<br>* Other names: Trastuzumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-Study Duration of Trial Treatment |  | From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) | 
| Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%) |  | From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up) | 
| Number of Participants Withdrawn From Study Because of LVEF Dysfunction | LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline. | From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) |