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
2 other identifiers
interventional
69
17 countries
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 1999
Longer than P75 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
March 29, 2016
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedMarch 31, 2017
February 1, 2017
15.7 years
March 24, 2016
February 13, 2017
February 13, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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Number of Participants Withdrawn From Study Because of LVEF Dysfunction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)
Study Arms (1)
Herceptin
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Liverpool, New South Wales, 2170, Australia
Unknown Facility
Waratah, New South Wales, 2298, Australia
Unknown Facility
Brisbane, Queensland, 4006, Australia
Unknown Facility
Brisbane, Queensland, 4066, Australia
Unknown Facility
Fitzroy, Victoria, 3065, Australia
Unknown Facility
Geelong, Victoria, 3220, Australia
Unknown Facility
Parkville, Victoria, 3052, Australia
Unknown Facility
Brussels, 1090, Belgium
Unknown Facility
Beijing, 100021, China
Unknown Facility
Beijing, 100142, China
Unknown Facility
Marseille, 13273, France
Unknown Facility
Berlin, 12203, Germany
Unknown Facility
Göttingen, 37075, Germany
Unknown Facility
Hamburg, 20246, Germany
Unknown Facility
Heidelberg, 69120, Germany
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Lübeck, 23538, Germany
Unknown Facility
München, 80637, Germany
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München, 81377, Germany
Unknown Facility
Trier, 54290, Germany
Unknown Facility
Guatemala City, 01010, Guatemala
Unknown Facility
Budapest, 1122, Hungary
Unknown Facility
Debrecen, 4032, Hungary
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Ramat Gan, 5262100, Israel
Unknown Facility
Auckland, 1023, New Zealand
Unknown Facility
Panama City, 0832-00752, Panama
Unknown Facility
Gdansk, 80-214, Poland
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Lisbon, 1099-023, Portugal
Unknown Facility
Izhevsk, 426009, Russia
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Moscow, 115478, Russia
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Saint Petersburg, 197758, Russia
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Belgrade, 11000, Serbia
Unknown Facility
Bundang City, 463-802, South Korea
Unknown Facility
Seoul, 03080, South Korea
Unknown Facility
Seoul, 120-752, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Unknown Facility
Alicante, Alicante, 3010, Spain
Unknown Facility
Barcelona, Barcelona, 08035, Spain
Unknown Facility
Edinburgh, EH4 2XU, United Kingdom
Unknown Facility
Glasgow, G12 0YN, United Kingdom
Unknown Facility
London, SE1 9RT, United Kingdom
Unknown Facility
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
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.
PMID: 29544445DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2016
First Posted
March 29, 2016
Study Start
June 1, 1999
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 31, 2017
Results First Posted
March 31, 2017
Record last verified: 2017-02