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

Sponsor: Ruth O'Regan

Sponsor score: 0

ClinicalTrials ID:NCT04886531

Provider View

This study is testing a combination of medications, including neratinib, hormone therapy, and trastuzumab, given before surgery to treat certain types of breast cancer. The goal is to see if this approach can effectively manage ER-positive, HER-2 positive breast cancers.

Patient Parameters

Program Overview

In this study, patients will receive a combination of treatments before surgery to see if it helps control their breast cancer. The treatment includes neratinib, a hormone therapy (aromatase inhibitor), and trastuzumab. Initially, patients will take neratinib alone, hormone therapy alone, or both together for three weeks. After that, all three medications will be given for 24 weeks before surgery. A breast biopsy will be done before starting the full treatment. After surgery, patients will continue with standard treatments as decided by their doctor.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and agree to share health information.
  • Must be 18 years or older.
  • Must be a postmenopausal woman, which can be due to age, surgery, or natural menopause.
  • Must have a good overall health status (ECOG score of 0-2).
  • Must have stage I-III invasive breast cancer larger than 10mm.
  • Cancer must be HER2-positive and ER-positive.
  • Cancer must be operable and suitable for pre-surgery treatment.
  • Must provide a tissue sample from a previous biopsy.
  • Must agree to a repeat breast biopsy after 3 weeks of treatment.
  • Must be suitable for letrozole or anastrozole treatment.
  • Must have a heart function of 50% or higher.
  • Must have adequate blood, kidney, and liver function based on specific tests.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with hepatitis B or C must have undetectable viral loads.
  • Must understand and agree to follow study procedures.

Exclusion Criteria

  • Cannot have locally advanced or inflammatory breast cancer.
  • Cannot have cancer that has spread to other parts of the body.
  • Cannot have other cancers that might interfere with the study, except for certain skin or cervical cancers.
  • Cannot have active infections needing treatment.
  • Cannot use certain medications that affect the study drugs.
  • Cannot have taken experimental drugs recently.
  • Cannot have had major surgery recently or have unresolved side effects from surgery.
  • Cannot have digestive issues that affect drug absorption.
  • Cannot have a history of certain blood disorders or leukemia.
  • Cannot have certain heart conditions or recent heart events.
  • Cannot have uncontrolled medical conditions that pose safety risks.

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