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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureEndocrine Therapy
Undergo endocrine therapy
- ProcedureBiopsy of breast
Undergo breast biopsy
- DrugNeratinib
Taken by mouth
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureMammogram
Undergo Mammogram
- ProcedureMagnetic Resonance Imaging
Undergo breast Magnetic Resonance Imaging
- ProcedureBreast Surgery
Undergo Breast Surgery
Locations (5)
- Emory University/ Winship Cancer InstituteAtlanta, Georgia
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Vanderbilt University/Ingram Cancer CenterNashville, Tennessee
- University of Texas, SouthwesternDallas, Texas
- Baylor College of MedicineHouston, Texas