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Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started2024-01-17
View on ClinicalTrials.gov ↗

Amendment history

2026-08-16
Study Status v6
Primary completion dateestimated 2026-06-30→confirmed 2026-07-18
2026-01-29
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2025-09-21
Study Status, Oversight v4
Re-verified, no change to tracked fields
2024-08-08
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v3
InterventionsPlacebo, epirubicin or doxorubicin, cyclophosphamide, paclitaxel (Drug), Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel…→Epirubicin or doxorubicin, cyclophosphamide, paclitaxel (Drug), Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel (Drug)
Eligibility criteria+5 characters
[...] TNM stage-IIb/III, or TNM stage-IIa with high risk (N+, G3, G2or withMammaPrint Ki67 ≥ 20%High-risk) At least one evaluable target breast lesion according to R [...]
Study title-32 characters
Neoadjuvant Pyrotinib Versus Placebo Combined With Chemotherapy in HR-positive and HER2-low High-risk Early Breast Cancer
2024-01-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01-01→confirmed 2024-01-17
Study sitesdetails revised at 1 of 1 site
2024-01-03
Study Status v1
Re-verified, no change to tracked fields
2023-11-17
Original filing
This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer
Trial Details
NCT Number NCT06144944
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Conditions Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer
Enrollment 160 participants
Start Date 2024-01-17
Primary Completion 2026-07-18 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-18