Vanderbilt-Ingram Cancer Center
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.
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…
Inclusion Criteria: Each patient will be entered into this study only if all of these criteria are met: * Subjects aged 18 years or older at signing of informed consent. * New diagnosis of clinical stage I-III HR+ histologically-proven (i.e. absent or decreased e-cadherin expression) invasive lobular carcinoma * Synchronous breast tumors are permitted as long as the synchronous tumor is ER+ and HER2-negative. * ER+ disease defined as ≥1% estrogen receptor (ER) positive consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Societ…
Undergo endocrine therapy
Undergo breast biopsy
Taken by mouth
Undergo collection of blood samples
Undergo Mammogram
Undergo breast Magnetic Resonance Imaging
Undergo Breast Surgery
Undergo Ultrasound