Using neratinib to treat HER2-mutated lobular breast cancer before surgery
Official title: Neoadjuvant Neratinib in Stage I-III HER2-mutated Lobular Breast Cancer
Funded at Vanderbilt University Medical Center · NIH-10894288 · Data updated 2026-11-12
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 type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Vanderbilt University Medical Center NIH-funded |
| Lab location | 1 site (Nashville, United States) |
| Project start | July 26, 2023 |
| Project end | June 30, 2028 |
| Funding year | 2024 |
| Award (this year) | $546,296 |
| NIH project number | 5R01CA273246-02 |
| Project ID | NIH-10894288 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are patients diagnosed with Stage I-III invasive lobular carcinoma who have HER2 mutations.
✕Less likely to help
Patients with lobular breast cancer who do not have HER2 mutations or those with advanced metastatic disease may not benefit from this research.
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.
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 gone: 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
-
Vanderbilt University Medical Center
Nashville, United States Active
Researchers
- Principal investigator: Kennedy, Laura Carpin — Vanderbilt University Medical Center
- Study coordinator: Kennedy, Laura Carpin
Related research
Other NIH-funded projects on the same topics.
-
Improving Breast Cancer Guideline Adherence in Nigeria
Aimed at helping doctors in Nigeria follow international guideline-based breast cancer care to improve outcomes for women with breast cancer.
-
Genomic study to understand how genetics and epigenetics shape triple-negative breast cancer in African ancestry
This study looks at how inherited genes and gene activity affect triple-negative breast cancer in people of African ancestry to better understand why outcomes can be worse.
-
Translational breast cancer research to improve treatment options
A comprehensive program at Baylor College of Medicine is focusing on breast cancer; researchers will advance targeted therapies and biomarkers to help patients with aggressive or hard-to-treat forms.
-
Cancer Pain Management for Asian American Breast Cancer Survivors with Depressive Symptoms
A technology-based program helps Asian American breast cancer survivors with depressive symptoms manage chronic pain more effectively from home using a web app and mobile tools.
-
Co-Targeting IL-6 and CDK4/6 to Prevent TNBC in Women Veterans
A study aims to block two cancer-promoting pathways (IL-6 and CDK4/6) to prevent or reduce progression of triple-negative breast cancer in women veterans.
-
Gut bacteria and metabolites linked to breast density and cancer risk
A small, patient-friendly study will explore whether gut bacteria and their byproducts are connected to high breast density, which can raise cancer risk and make screening less accurate.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.