Neratinib with hormone therapy before surgery for HER2-mutant lobular breast cancer
Neoadjuvant Neratinib in Stage I-III HER2-mutated Lobular Breast Cancer
['FUNDING_R01'] · VANDERBILT UNIVERSITY MEDICAL CENTER · NIH-11131267
This trial compares neratinib plus hormone therapy versus hormone therapy alone given before surgery for people with HER2-mutated invasive lobular breast cancer.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | VANDERBILT UNIVERSITY MEDICAL CENTER (nih funded) |
| Locations | 1 site (NASHVILLE, UNITED STATES) |
| Trial ID | NIH-11131267 on ClinicalTrials.gov |
What this research studies
You would join a Phase II, multi-site trial enrolling about 30 people with Stage I–III invasive lobular breast cancer that carries a HER2 (ERBB2) mutation. Participants are randomized to receive either neratinib together with endocrine (hormone) therapy or endocrine therapy alone for an initial 4-week window, followed by a biopsy to check early tumor changes. Treatment continues up to surgery while doctors monitor tumor response, molecular changes, and side effects. The study is unblinded and led from Vanderbilt University Medical Center with other participating sites.
Who could benefit from this research
Good fit: Ideal candidates are people with Stage I–III, hormone receptor–positive invasive lobular breast cancer whose tumor testing shows a HER2 (ERBB2) mutation.
Not a fit: People without a HER2 mutation, those with HER2-amplified disease or non-lobular breast cancers, and patients unable to take neratinib or standard endocrine therapy are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the combination could shrink tumors before surgery and improve response and longer-term outcomes for people with HER2-mutant lobular breast cancer.
How similar studies have performed: Neratinib is FDA-approved in certain HER2-amplified early breast cancers and has shown activity with endocrine therapy in metastatic HER2-mutant breast cancer, but using neratinib before surgery in HER2-mutant lobular cancer is a newer approach.
Where this research is happening
NASHVILLE, UNITED STATES
- VANDERBILT UNIVERSITY MEDICAL CENTER — NASHVILLE, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: KENNEDY, LAURA CARPIN — VANDERBILT UNIVERSITY MEDICAL CENTER
- Study coordinator: KENNEDY, LAURA CARPIN
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 below.