Status:
RECRUITING
Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease
Lead Sponsor:
University Health Network, Toronto
Conditions:
Breast Cancer
HER2-positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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.
- 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
- Previous Therapy requirements:
- Received 2-6 cycles of trastuzumab-DM1 in the adjuvant setting
- Received min of 12 weeks of endocrine therapy (ER+ patients)
- Adjuvant radiation permitted (minimum 14-day washout required)
- No prior neratinib or other HER2 tyrosine kinase inhibitor
- ECOG performance status 0-1.
- Patient must have adequate organ function
- WOCBP must have a negative serum \[beta\] HCG test result.
- WOCBP must agree to use highly effective contraception
- Male participants must agree to use highly effective contraception
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Signed informed consent
Exclusion
- 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, with exceptions
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Known positive serology for HIV that is not currently controlled with anti-retroviral therapy,
- Has a known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (defined as HCV RNA \[qualitative\] is detected). HBV DNA must be undetectable and HBsAg negative at Screening Visit. Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at Screening Visit.
- Impaired gastrointestinal function or disease that may significantly alter the absorption of neratinib
- Medical, psychiatric, cognitive, or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol, or complete the study.
Key Trial Info
Start Date :
December 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05388149
Start Date
December 6 2022
End Date
July 1 2026
Last Update
January 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Health Network: Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5