OncoMatch/Clinical Trials/NCT05760612
Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab
Is NCT05760612 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Trastuzumab and neratinib and Trastuzumab and Pertuzumab for early-stage breast cancer.
Treatment: Trastuzumab and neratinib · Trastuzumab and Pertuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 estrogen receptor expression ≥1% (≥1%)
estrogen receptor ≥1%
Required: PR (PGR) progesterone receptor expression ≥1% (≥1%)
progesterone receptor ≥1%
Required: HER2 (ERBB2) overexpression (IHC 3+ or FISH-positive)
HER2-positive (immunohistochemistry 3+ or fluorescence in situ hybridization-positive)
Disease stage
Required: Stage CT1-4/N1-3/M0, CT1MI/N0, CT1A-B/N0 (AJCC 8th edition)
Excluded: Stage IV
Clinical stage at initial diagnosis (per the 8th edition of the American Joint Committee on Cancer Staging Manual): cT1-4/N1-3/M0 (cT1mi/N0 or cT1a-b/N0 are eligible)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: trastuzumab (trastuzumab) — neoadjuvant
Completion of ≥4 cycles of neoadjuvant therapy with trastuzumab and pertuzumab
Must have received: pertuzumab (pertuzumab) — neoadjuvant
Completion of ≥4 cycles of neoadjuvant therapy with trastuzumab and pertuzumab
Cannot have received: tyrosine kinase inhibitor (pyrotinib, lapatinib, neratinib)
Prior treatment with pyrotinib, lapatinib, neratinib, or other tyrosine kinase inhibitors
Cannot have received: antibody-drug conjugate (trastuzumab emtansine)
trastuzumab emtansine
Cannot have received: antitumor biological or immunotherapy
any antitumor biological or immunotherapy
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L; Platelet count ≥90 × 10⁹/L; Hemoglobin ≥90 g/L
Liver function
Total bilirubin ≤1.5 × ULN; ALT and AST ≤1.5 × ULN
Cardiac function
LVEF ≥50% during screening, with an absolute decrease of ≤15% compared to pre-chemotherapy values; if no pre-chemotherapy LVEF assessment is available, LVEF must be ≥55% during screening
Adequate organ function within 2 weeks prior to screening (without transfusion or use of growth factors): Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥90 × 10⁹/L; Hemoglobin ≥90 g/L; Total bilirubin ≤1.5 × ULN; Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN; Post-neoadjuvant therapy echocardiography showing left ventricular ejection fraction (LVEF) ≥50% during screening, with an absolute decrease of ≤15% compared to pre-chemotherapy values; if no pre-chemotherapy LVEF assessment is available, LVEF must be ≥55% during screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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