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.

Trial Details

NCT ID
NCT05919108
Phase
PHASE2
Sponsor
Vanderbilt-Ingram Cancer Center
Status
RECRUITING
Cancer Type
Lobular Carcinoma Breast Cancer
Interventions
  • Endocrine Therapy
  • Biopsy of breast
  • Neratinib
  • Biospecimen Collection
  • Mammogram
  • Magnetic Resonance Imaging
Locations (sample)
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Dallas, Texas, United States|32.78306,-96.80667
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Lobular Carcinoma Breast Cancer Trials on Trialify →