At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 338 enrolled
Drug / intervention
TX05 (trastuzumab) +1 morebiological
Likely dose
Not stated in 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.
A Double-blinded Extension Study to Provide Adjuvant Treatment With Single Agent Herceptin® or TX05 and Assess Continued Safety and Immunogenicity in Subjects With HER2-positive Early Breast Cancer Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
In Brief
A Phase 3 clinical trial evaluating TX05 (trastuzumab) and Herceptin (trastuzumab) for HER2-positive Breast Cancer and 5 related conditions. Completed, enrolled 338 participants across 86 sites in 10 countries.
Detailed Summary
This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer, Breast Neoplasms, Stage II Breast Cancer, Stage IIIA Breast Cancer
CountriesBelarus, Chile, Georgia, Hungary, India, Mexico, Peru, Philippines, Russia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartAug 2019
First PostedSep 2019
Primary CompletionDec 2021
Study CompletionMar 2022
TodayJul 2026
First PostedSep 30, 2019
Enrollment StartAug 20, 2019
Primary CompletionDec 25, 2021
Study CompletionMar 8, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.8 years ago
Interventions
TX05 (trastuzumab)biological
Subjects will receive up to 13 cycles of adjuvant treatment.
Herceptin (trastuzumab)biological
Subjects will receive up to 13 cycles of adjuvant treatment.