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

Recruiting Phase 2 Interventional Study
Breast Cancer HER2-positive Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
University Health Network, Toronto · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age with histologically confirmed, resected HER2 positive stage I-III breast cancer, with residual invasive disease following prior neoadjuvant trastuzumab (+/- pertuzumab)-based chemotherapy. 2. Receiving adjuvant T-DM1, with evidence of…
Contacts

David Cescon, MD PhD

416-946-2245

Dave.cescon@uhn.ca

CONTACT