RecruitingPhase 2NCT05388149

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

Sponsor

University Health Network, Toronto

Enrollment

15 participants

Start Date

Dec 6, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer HER2-positive Breast Cancer

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two HER2-targeted treatments — Kadcyla (an antibody that delivers chemotherapy directly to HER2-positive cancer cells) and neratinib (a pill that blocks HER2 signaling from multiple angles) — can prevent HER2-positive breast cancer from returning in patients who still had cancer remaining after surgery and initial chemotherapy. **You may be eligible if...** - You are 18 or older - You have HER2-positive breast cancer (stage I to III) that was surgically removed - After pre-surgery chemotherapy, cancer was still found in your breast tissue or lymph nodes - You have not yet completed more than one cycle of Kadcyla (T-DM1) post-surgery **You may NOT be eligible if...** - You have previously taken a HER2 tyrosine kinase inhibitor (such as lapatinib, neratinib, or tucatinib) - There is evidence your cancer has spread to other parts of the body - You have had another cancer in the past 5 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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