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Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

StatusActive, Not Recruiting
PhasePhase 2/3
Started2020-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-01-05
Not Yet Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2022-03-01→2026-12-01
Completion date2024-03-01→2026-12-10
Enrollment target280→113
Study sites0→1
Study arms2→1
Eligibility criteriarevised
Inclusion Criteria: Female breast cancer patients at the age of >= 18 years and <= 6570 years who received first treatment； Pathologically confirme [...]
Secondary endpoints4 entries, revised
EventbpCR Adverse FreeEvents Survival(EFS) Overall survival (OS)rate
Primary endpoints1 entry, revised
Pathological Complete Response rate(pCR)tpCR
2020-02-27
Original filing
This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
Trial Details
NCT Number NCT04290793
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions Breast Cancer
Enrollment 113 participants
Start Date 2020-03-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-07