At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 275 enrolled
Drug / intervention
trastuzumab monotherapy +1 moredrug
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.
Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial
Comprehensive Support Project for Oncology Research·interventional·Posted Apr 16, 2010·Updated Oct 21, 2019
In Brief
A Phase 3 clinical trial evaluating trastuzumab monotherapy and trastuzumab and chemotherapy for Breast Cancer. Completed, enrolled 275 participants across 1 site.
Detailed Summary
To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized controlled trial in women over 70 years with human epidermal growth factor receptor type-2 (HER2) positive primary breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedApr 2010
Primary CompletionOct 2017
Study CompletionOct 2018
TodayJul 2026
First PostedApr 16, 2010
Enrollment StartOct 28, 2009
Primary CompletionOct 31, 2017
Study CompletionOct 15, 2018
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 16.2 years ago
Interventions
trastuzumab monotherapydrug
trastuzumab and chemotherapydrug