Using neratinib to treat HER2-mutated lobular breast cancer before surgery

Neoadjuvant Neratinib in Stage I-III HER2-mutated Lobular Breast Cancer

NIH-funded research Vanderbilt University Medical Center · NIH-10894288

This study is looking at how well a new treatment combining neratinib with hormone therapy works for patients with early-stage invasive lobular breast cancer that has HER2 mutations, hoping to improve surgery results and lower the chances of cancer coming back.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionVanderbilt University Medical Center NIH-funded
Lab location1 site (Nashville, United States)
Project IDNIH-10894288 on NIH RePORTER

What this research studies

This research investigates the effectiveness of neratinib, a targeted therapy, combined with endocrine therapy for patients with Stage I-III invasive lobular carcinoma (ILC) that has HER2 mutations. The study aims to improve surgical outcomes and reduce the risk of cancer recurrence by administering this combination treatment before surgery. Patients will be randomly assigned to receive either the combination therapy or endocrine therapy alone for a short period, followed by biopsies to assess the treatment's impact. This approach seeks to provide a new treatment option for a specific subset of breast cancer patients who currently have limited effective therapies.

Who could benefit from this research

Good fit: Ideal candidates for this research are patients diagnosed with Stage I-III invasive lobular carcinoma who have HER2 mutations.

Not a fit: Patients with lobular breast cancer who do not have HER2 mutations or those with advanced metastatic disease may not benefit from this research.

Why it matters

Potential benefit: If successful, this research could lead to improved treatment options and outcomes for patients with HER2-mutated lobular breast cancer.

How similar studies have performed: Previous research has shown promising results with neratinib in other HER2-positive breast cancer contexts, suggesting potential for success in this novel application.

Where this research is happening

Nashville, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.