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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT05760612 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tyrosine kinase inhibitor, antibody-drug conjugate, antitumor biological or immunotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 estrogen receptor expression ≥1% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR progesterone receptor expression ≥1% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT1-4/N1-3/M0 or CT1MI/N0 or CT1A-B/N0 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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