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
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Herceptin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 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
- On-Study Duration of Trial Treatment [ Time Frame: 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) ]
- Number of Participants Withdrawn From Study Because of LVEF Dysfunction [ Time Frame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) ]LVEF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.
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
|Study Chair:||Clinical Trials||Hoffmann-La Roche|