CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,577 enrolled
Drug / intervention
Herceptindrug
Likely dose
Herceptin 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01566721
NCT01566721Phase 3Completed
CompareCT.gov

A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

Hoffmann-La Roche·interventional·Posted Mar 29, 2012·Updated Apr 27, 2021

In Brief

A Phase 3 clinical trial evaluating Herceptin for Breast Neoplasms. Completed, enrolled 2,577 participants across 437 sites in 59 countries.

Detailed Summary

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesAlbania, Algeria, Argentina, Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Italy, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2012
Enrollment StartMay 17, 2012
Primary CompletionMar 10, 2015
Study CompletionFeb 19, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.3 years ago

Interventions

Herceptindrug

Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.