OncoMatch/Clinical Trials/NCT05388149
Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease
Is NCT05388149 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Neratinib for breast cancer.
Treatment: Neratinib — This is a Phase 2 study for patients with resected Stage I-III HER2+ breast cancer with detected molecular residual disease (MRD+) following standard neoadjuvant and locoregional therapy delivered with curative intent. In this study Patients will be treated with neratinib in addition to their standard T-DM1 adjuvant therapy. Neratinib will be administered orally at a dose of 160 mg daily for up to 12 months, or until the time of clinical recurrence, discontinuation due to toxicity, or withdrawal of consent. This study will have two stages, stage 1 would enroll up to 8 participants to clear the Minimal Residual Disease (MRD) and Stage 2 will enroll up to 5 participants. The purpose of this study is to determine if this study population would have a better outcome from adding neratinib to their standard T-DM1 adjuvant therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Disease stage
Required: Stage I, II, III
Excluded: Stage IV
stage I-III breast cancer, with residual invasive disease following prior neoadjuvant trastuzumab (+/- pertuzumab)-based chemotherapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: antibody-drug conjugate (trastuzumab-dm1) — adjuvant
Must have received: endocrine therapy — adjuvant
Cannot have received: her2 tyrosine kinase inhibitor (neratinib)
Lab requirements
Blood counts
Kidney function
Liver function
Patient must have adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05388149 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior her2 tyrosine kinase inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages