Eligible patients: Individuals over 18 years of age newly diagnosed with clinical stage I-III HR+ invasive lobular carcinoma, with a minimum tumor size of at least 1.5 cm identified on US, mammogram, MRI imaging, or clinical breast exam. At the time of screening, participants must have a documented activating HER2 mutation confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent laboratory. To be eligible, individuals may not have had prior treatment for current diagnosis of breast cancer.
Where can patients enroll? Participants will need to be seen, screened, and treated at an open trial site. The study is currently open at Vanderbilt and there are several other sites that will be opening and enrolling soon (See site list below).
Description of Trial/Summary:Â 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.
Why is this study beneficial?/Important?
Invasive lobular carcinoma (ILC) is a form of breast cancer that does not respond well to standard treatments like chemotherapy and hormone blockers and as a result is more likely to recur. HER2 activating mutations are found in a small percentage of ILC, and this oncogenic mutation can be treated with tyrosine kinase inhibitors such as neratinib. This study will use neratinib in combination with antiestrogens to treat early-stage ILC with the goal of demonstrating the clinical activity of the combination, improving breast conservation, and eventually, increasing the number of patients who have breast cancer cure.
Principal Investigator:
Laura Kennedy, MD, PhD
Vanderbilt University/Ingram Cancer Center
More information /Trial Contact:
Vanderbilt-Ingram Services for Timely Access
Phone Number: 800-811-8480
Email Address: cip@vumc.org
Trial Location(s):/Any limits to enrollment re:Â geography or citizenry.
Tennessee Location
Nashville, Tennessee, United States, 37203
Recruiting
Vanderbilt University/Ingram Cancer Center
Contact: Vanderbilt-Ingram Service for Timely Access
800-811-8480 cip@vumc.org
Principal Investigator: Laura Kennedy, MD, PhD
Georgia Location
Atlanta, Georgia, United States, 30322
Not yet recruiting
Emory University/ Winship Cancer Institute
Principal Investigator: Kevin Kalinsky, MD
Pennsylvania Location
Pittsburgh, Pennsylvania, United States, 15213
Not yet recruiting
University of Pittsburgh Medical Center
Principal Investigator: Julia Foldi, MD
Texas Locations
Dallas, Texas, United States, 75390
Not yet recruiting
University of Texas, Southwestern
Principal Investigator: Nisha Unni, MD
Houston, Texas, United States, 77030
Not yet recruiting
Baylor College of Medicine
Principal Investigator: Ahmed Elkhanany, MD
For more information: https://clinicaltrials.gov/study/NCT05919108
