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

February 13, 2017 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
      • Waratah, New South Wales, Australia, 2298
    • Queensland
      • Brisbane, Queensland, Australia, 4066
      • Brisbane, Queensland, Australia, 4006
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
      • Geelong, Victoria, Australia, 3220
      • Parkville, Victoria, Australia, 3052
  • Belgium
      • Brussel, Belgium, 1090
  • China
      • Beijing, China, 100021
      • Beijing, China, 100142
  • France
      • Marseille, France, 13273
  • Germany
      • Berlin, Germany, 12203
      • Göttingen, Germany, 37075
      • Hamburg, Germany, 20246
      • Heidelberg, Germany, 69120
      • Lübeck, Germany, 23538
      • Muenchen, Germany, 80637
      • Muenchen, Germany, 81377
      • Trier, Germany, 54290
  • Guatemala
      • Guatemala City, Guatemala, 01010
  • Hungary
      • Budapest, Hungary, 1122
      • Debrecen, Hungary, 4032
  • Israel
      • Ramat Gan, Israel, 5262100
  • Korea, Republic of
      • Bundang City, Korea, Republic of, 463-802
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 03080
      • Seoul, Korea, Republic of, 120-752
  • New Zealand
      • Auckland, New Zealand, 1023
  • Panama
      • Panama City, Panama, 0832-00752
  • Poland
      • Gdansk, Poland, 80-214
  • Portugal
      • Lisboa, Portugal, 1099-023
  • Russian Federation
      • Izhevsk, Russian Federation, 426009
      • Moscow, Russian Federation, 115478
      • Saint-Petersburg, Russian Federation, 197758
  • Serbia
      • Belgrade, Serbia, 11000
  • Spain
      • Alicante, Spain, 3010
      • Barcelona, Spain, 08035
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
      • Glasgow, United Kingdom, G12 0YN
      • London, United Kingdom, SE1 9RT
      • Nottingham, United Kingdom, NG5 1PB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Herceptin
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
On-Study Duration of Trial Treatment
Time Frame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
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)
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.
From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO15943
  • 2007-000348-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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