Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease

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

Trial Details

NCT ID
NCT05388149
Phase
PHASE2
Sponsor
University Health Network, Toronto
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Neratinib
Locations (sample)
  • Toronto, Ontario, Canada|43.70643,-79.39864

Key Eligibility Criteria

  • Male or female patients ≥ 18 years of age with histologically confirmed, resected HER2 positive stage I-III breast cancer, with residual invasive d…
  • Receiving adjuvant T-DM1, with evidence of MRD (positive test by Inivata RaDaR) after receiving 2-6 cycles of T-DM1
  • No contraindications to T-DM1 or neratinib
  • No clinical or radiographic evidence of recurrent or metastatic disease

For full eligibility, visit ClinicalTrials.gov.

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