Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Vanderbilt-Ingram Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. Determine efficacy of neoadjuvant neratinib in combination with endocrine therapy. SECONDARY OBJECTIVES: I. Determine additional efficacy outcomes of neoadjuvant neratinib in combination with endocrine therapy. II. Compare the safety and tolerability of neratinib plus endocrine therapy. CORRELATIVE OBJECTIVE: I. Establish HER2-mutant invasive lobular carcinoma (ILC) organoids. OUTLINE: Patients are randomized to 1 of 2 treatments. TREATMENT A: Patients receive standard of care endocrine therapy over 4 weeks for 1 cycle. Patients undergo breast tissue biopsy during…