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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Neratinib administered as 40mg tablets
University Health Network: Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGClearance of ctDNA with the addition of neratinib to trastuzumab-DM1 in patients with MRD detectable by the RaDaR assay, following standard neoadjuvant therapy, surgery, and initiation of T-DM1
Time frame: At week 12
Clinical outcomes for MRD+ patients treated with escalated strategy, including invasive breast cancer-free survival (IBCFS) measured by Invasive Breast Cancer-Free Survival and Distant Metastasis Free Survival
Time frame: Up to 3 years
Toxicities of the combination of neratinib and trastuzumab-DM1 in the study population measured by CTCAE 5.0
Time frame: Up to 3 years
Characterize dynamic changes and kinetics in ctDNA MRD+ for enrolled patients measured by ctDNA MRD Detection by RaDaR assay
Time frame: Up to 3 years
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