At a glance
ClinicalIndex Comparison RecordPhase 3Unknown· 1,192 enrolled
Drug / intervention
Pyrotinib +1 moredrug
Likely dose
Pyrotinib 400 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.
A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab
In Brief
A Phase 3 clinical trial evaluating Pyrotinib and Placebo for Breast Cancer. Targeting 1,192 participants across 1 site.
Detailed Summary
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--
Timeline
Phase 3UnknownOverdue
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJul 2019
Primary CompletionJul 2022
Study CompletionJul 2024
TodayJul 2026
First PostedJun 10, 2019
Enrollment StartJul 12, 2019
Primary CompletionJul 31, 2022
Study CompletionJul 31, 2024
TodayJul 1, 2026
Enrollment to primary: 3.1 yearsPosted 7.1 years ago
Interventions
Pyrotinibdrug
pyrotinib 400 mg, orally once daily for one year
Placebodrug
placebo 400mg, orally once daily for one year