CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 69 enrolled
Drug / intervention
Herceptindrug
Likely dose
Trastuzumab 2 mg/kg once weekly (4 mg/kg loading dose) or 6 mg/kg every 3 weeks (8 mg/kg loading dose) IV infusion over 90 minutesAI-extracted
Key inclusion· 3
  • ✓Participants who completed a prior Roche-sponsored Herceptin trial
  • ✓At least stable disease (or no disease recurrence) during prior Herceptin therapy
  • ✓Available baseline study termination data from prior trial including tumor assessment and laboratory data
Key exclusion· 4
  • ✕Pregnant or nursing women
  • ✕Women of childbearing potential without effective contraception
  • ✕Severe dyspnea at rest requiring supplementary oxygen
  • ✕Severe uncontrolled systemic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02721641
NCT02721641Phase 3Completed
CompareCT.gov

A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors

Hoffmann-La Roche·interventional·Posted Mar 29, 2016·Updated Mar 31, 2017

In Brief

A Phase 3 clinical trial evaluating Herceptin for Neoplasms. Completed, enrolled 69 participants across 41 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesAustralia, Belgium, China, France, Germany, Guatemala, Hungary, Israel, New Zealand, Panama, Poland, Portugal, Russia, Serbia, South Korea, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 29, 2016
Enrollment StartJun 1, 1999
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 15.7 yearsPosted 10.3 years ago

Interventions

Herceptindrug

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.