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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Liverpool, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herceptin

Drug

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.

Other names: Trastuzumab

Primary outcomes

On-Study Duration of Trial Treatment

Time frame: 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 (%)

Time frame: 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Number of Participants Withdrawn From Study Because of LVEF Dysfunction

Time frame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)

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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 1999
Primary completion: 2015
Study completion: 2015
First posted: Mar 29, 2016
Registry last updated: Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed