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Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer

NCT07729046 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-27

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2/3/4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+/HER2-negative breast cancer. Neratinib is already approved for the treatment of HER2-postive breast cancers. The study will also learn about the safety of adding this drug to standard of care treatments. The main questions it aims to answer are:

1. Does adding neratinib to standard of care systemic therapy improve disease control for patients with metastatic hormone-driven breast cancer that is resistant to endocrine therapy?
2. What side effects do participants have when adding neratinib to standard of care therapy? Researchers will compare standard of care endocrine therapy regimens with and without neratinib to see if neratinib improves control of treatment-resistant metastatic breast cancer that has continued to progress while eon first line endocrine therapy.

Participants will:

1. Take standard of care endocrine therapy for metastatic endocrine-resistant breast cancer as determined by their medical oncologist or standard of care therapy with neratinib daily
2. Visit the clinic every 3 months for checkups, tests and imaging studies

Conditions

  • Metastatic Invasive Breast Cancer
  • Resistant Breast Cancer
  • ER+, HER2-, Metastatic Breast Cancer

Interventions

DRUG

Neratinib + endocrine therapy

Neratinib 120mg daily for 1 week, 160mg daily for 1 week and then 240mg daily thereafter

DRUG

Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant

Endocrine therapy with out without CDK4/6 inhibitor

DRUG

CDK4/6 + Endocrine therapy

Endocrine therapy with or without CDK 4/6 inhibitor

Sponsors & Collaborators

Principal Investigators

  • Asona Lui, MD, PhD · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-07-31
Primary Completion
2032-05-31
Completion
2035-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729046 on ClinicalTrials.gov