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A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started2019-07-12
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
Study Status, Study Design v4
Primary completion date2022-07-31→2027-06
Completion date2024-07-31→2027-06
Enrollment target1192→2135
2021-05-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Start date2019-07-15→2019-07-12
Study sitesdetails revised at 1 of 1 site
2021-01-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-06-15→confirmed 2019-07-15
Study sites0→1
2019-06-07
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria-18 characters
[...] Oncology Group (ECOG) 0-1 Histologically confirmed invasive HER2 positive breast cancer. HER2 positive (HER2+++ by IHC or FISH +). Known hormone receptor status. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHOEchocardiogram. Been treated for early breast cancer with standard of care [...]
Secondary endpoints3 entries, revised
Overall survivalSurvival （(OS）)
2019-06-06
Original filing
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.
Trial Details
NCT Number NCT03980054
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Breast Cancer
Enrollment 2,135 participants
Start Date 2019-07-12
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-17