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Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab

StatusRecruiting
PhasePhase 3
Started2023-03-14
View on ClinicalTrials.gov ↗

Amendment history

2025-09-21
Study Identification, Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility v4
InterventionsTrastuzumab and Parstuzumab (Drug), Trastuzumab and nelatinib (Drug)→Trastuzumab and Pertuzumab (Drug), Trastuzumab and neratinib (Drug)
Eligibility criteria-1,992 characters
Inclusion Criteria: Female patients ≥aged 18 years old and ≤ -70 years old; ECOGEastern scoreCooperative Oncology Group performance status of 0- or 1; TheClinical clinical stagingstage at the time of initial diagnosis (according toper the 8th edition of the American Joint CommissionCommittee on Cancer [AJCC] Cancer Staging Manual): cT4/any N/M0, any cT/N2 - 3/M0 or cT1-4/N1-3/N0-1/M0 (cT1mi/T1a/T1bN0 or cT1a-b/N0 patients are not eligible), atmeeting the timecriteria offor initialneoadjuvant diagnosistherapy meetsas theper newNCCN adjuvant2022 treatment standard (NCCN2022 guidance of the Natio [...] [...]
Secondary endpoints3 to 4 entries
Disease free survival, DFS Overall survival, ，OS Distant disease free survival，, DDFS
Primary endpoints1 entry, revised
Invasive disease free survival，, IDFS
Study title+22 characters
AAdjuvant ClinicalTrastuzumab StudyPlus onNeratinib in Hormone Receptor-Positive/Human PositiveEpidermal HER2Growth Factor Receptor 2-Positive Breast Cancer of RCB1-2 After Neoadjuvant Treatment with Trastuzumab CombinedPlus with ParezumabPertuzumab
2024-11-26
Study Identification, Study Status, Oversight v3
Study titlerevised
A Clinical Study on Hormone Receptor Positive HER2 Positive Breast Cancer of RCB1-2 After Neoadjuvant Treatment Withwith Trastuzumab Combined Withwith Parezumab
2024-07-01
Study Status v2
Primary completion date2024-02-16→2028-02-16
Start date2023-02-16→2023-03-14
2023-03-12
Study Identification, Study Status, Conditions, Arms and Interventions v1
Interventionsnelatinib，Trastuzumab，Parstuzumab (Drug)→Trastuzumab and Parstuzumab (Drug), Trastuzumab and nelatinib (Drug)
Study title-47 characters
A Prospective, Randomized, Controlled, Phase III Clinical Study on Hormone Receptor Positive HER2 Positive B [...]
2023-02-26
Original filing
Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer following neoadjuvant therapy. Furthermore, there are no prospective randomized controlled trials comparing trastuzumab plus pertuzumab versus trastuzumab plus TKIs in HER2-positive breast cancer patients with residual cancer burden class (RCB) I or II after neoadjuvant trastuzumab and pertuzumab. Therefore, this study aimed to evaluate the efficacy and safety of adjuvant trastuzumab plus neratinib in patients with hormone receptor-positive/HER2-positive breast cancer and RCB 0/I following neoadjuvant trastuzumab and pertuzumab therapy.
Trial Details
NCT Number NCT05760612
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions Early-stage Breast Cancer, HER2-positive Breast Cancer, Adjuvant Treatment After Trastuzumab, RCB Classification 1-2, Neratini
Enrollment 300 participants
Start Date 2023-03-14
Primary Completion 2028-02-16 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-25