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

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ClinicalTrials.gov Identifier: NCT02721641
Recruitment Status : Completed
First Posted : March 29, 2016
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Herceptin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors
Study Start Date : June 1999
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

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 Name: Trastuzumab




Primary Outcome Measures :
  1. On-Study Duration of Trial Treatment [ Time Frame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) ]
  2. 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) ]
  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721641


  Show 41 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02721641     History of Changes
Other Study ID Numbers: BO15943
2007-000348-28 ( EudraCT Number )
First Posted: March 29, 2016    Key Record Dates
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents