Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.

NCT Number	NCT05919108
Lead Sponsor	Vanderbilt-Ingram Cancer Center Collaborators: National Cancer Institute (NCI), Puma Biotechnology, Inc.
Conditions	Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma
Enrollment	30 participants
Start Date	2024-05-30
Primary Completion	2030-04-30 (estimated)
Study Completion	2031-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-09