A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer
NCT ID: NCT02721641
Last Updated: 2017-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
69 participants
INTERVENTIONAL
1999-06-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Liverpool, New South Wales, Australia
Waratah, New South Wales, Australia
Brisbane, Queensland, Australia
Brisbane, Queensland, Australia
Fitzroy, Victoria, Australia
Geelong, Victoria, Australia
Parkville, Victoria, Australia
Brussels, , Belgium
Beijing, , China
Beijing, , China
Marseille, , France
Berlin, , Germany
Göttingen, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Lübeck, , Germany
München, , Germany
München, , Germany
Trier, , Germany
Guatemala City, , Guatemala
Budapest, , Hungary
Debrecen, , Hungary
Ramat Gan, , Israel
Auckland, , New Zealand
Panama City, , Panama
Gdansk, , Poland
Lisbon, , Portugal
Izhevsk, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Belgrade, , Serbia
Bundang City, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Alicante, Alicante, Spain
Barcelona, Barcelona, Spain
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2007-000348-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO15943
Identifier Type: -
Identifier Source: org_study_id
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