RecruitingPhase 2NCT04886531

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141

Sponsor

Ruth O'Regan

Enrollment

30 participants

Start Date

Jul 21, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer ER Positive Breast Cancer HER2-positive Breast Cancer PR-Positive Breast Cancer

Summary

Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving neratinib (a targeted HER2-blocking drug) plus endocrine therapy (hormone-blocking medication) combined with trastuzumab (another HER2-targeting drug) before breast cancer surgery can shrink tumors effectively in postmenopausal women with ER-positive, HER2-positive breast cancer. **You may be eligible if...** - You are a postmenopausal woman aged 18 or older - You have stage I–III invasive breast cancer larger than 10 mm - Your cancer is both HER2-positive and estrogen receptor-positive (ER+, at least 10%) - Your cancer is surgically removable and pre-operative therapy is appropriate - Your heart function is adequate (normal ejection fraction) - You can tolerate either letrozole or anastrozole (aromatase inhibitors) - A pre-treatment tissue biopsy is available, and you agree to a repeat biopsy 3 weeks into treatment - Your overall health score is 0–2 (ECOG) **You may NOT be eligible if...** - You have had prior treatment for this breast cancer - Your cancer is HER2-negative or ER-negative - Your breast cancer has already spread to other organs - You are not postmenopausal - You have significant heart, liver, or kidney problems 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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Interventions

DRUGNeratinib

120mg for 7 days; 160mg for 7 days ; 240mg for 7 days. 240 mg (up to a maximum of 24 weeks) orally daily\*.

DRUGLetrozole (L) or Anastrozole (A)

L: (2.5 mg) OR A: (1 mg) orally daily (up to a maximum of 24 weeks)\*

DRUGTrastuzumab

All Arms 8mg/kg loading dose followed by 6mg/kg every 3 weeks administered every 3 weeks by IV starting wk 4. Trastuzumab biosimilars may be used per institutional guidelines.