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Study identifier: NCT05760612 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Early-stage Breast Cancer · HER2-positive Breast Cancer · Adjuvant Treatment After Trastuzumab  ·  Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

PhasePhase 3
Planned participants300
Who can joinFemale, 18 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Chang Gong  ·  13925089353  ·  gchang@mail.sysu.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Sun Yat-sen University Sun Yat-sen Memorial HospitalGuangzhou, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT05760612