Actively Recruiting
Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease
Led by University Health Network, Toronto · Updated on 2025-01-31
15
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years or older with resected HER2-positive stage I-III breast cancer and residual invasive disease after prior neoadjuvant trastuzumab (+/- pertuzumab)-based chemotherapy
- Receiving adjuvant T-DM1 therapy with evidence of molecular residual disease (MRD) positive by Inivata RaDaR after 2-6 cycles of T-DM1
- No contraindications to T-DM1 or neratinib
- No clinical or radiographic evidence of recurrent or metastatic disease
- Received 2-6 cycles of trastuzumab-DM1 in the adjuvant setting
- Received a minimum of 12 weeks of endocrine therapy if ER positive
- Adjuvant radiation permitted with at least a 14-day washout period
- No prior neratinib or other HER2 tyrosine kinase inhibitor use
- ECOG performance status of 0-1
- Adequate organ function
- Women of childbearing potential (WOCBP) must have negative serum beta HCG test and agree to use highly effective contraception
- Male participants must agree to use highly effective contraception
- Willing and able to comply with study protocols, treatment, and scheduled visits including follow-up
- Signed informed consent
You will not qualify if you...
- Prior therapy with any HER2 tyrosine kinase inhibitor
- Clinical or radiographic evidence of suspected or confirmed metastatic disease
- Previous or concurrent malignancy within 3 years of study entry, except specified exceptions
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Known positive HIV serology uncontrolled by therapy
- Known history of or active hepatitis B or C infection, with specific screening requirements
- Impaired gastrointestinal function or disease that may affect neratinib absorption
- Medical, psychiatric, cognitive, or other conditions that could affect understanding, consent, compliance, or study completion
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Health Network: Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
Research Team
D
David Cescon, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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