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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: Herceptin

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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		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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Muller V, Clemens M, Jassem J, Al-Sakaff N, Auclair P, Nuesch E, Holloway D, Shing M, Bang YJ. Long-term trastuzumab (Herceptin(R)) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer. BMC Cancer. 2018 Mar 15;18(1):295. doi: 10.1186/s12885-018-4183-2.

Study record dates

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: Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: BO15943; 2007-000348-28 (EudraCT Number)