NCT05919108 · Vanderbilt-Ingram Cancer Center
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Endocrine Therapy
Undergo endocrine therapy
PROCEDURE
Biopsy of breast
Undergo breast biopsy
DRUG
Neratinib
Taken by mouth
PROCEDURE
Biospecimen Collection
Undergo collection of blood samples
PROCEDURE
Mammogram
Undergo Mammogram
PROCEDURE
Magnetic Resonance Imaging
Undergo breast Magnetic Resonance Imaging
PROCEDURE
Breast Surgery
Undergo Breast Surgery
PROCEDURE
Ultrasound
Undergo Ultrasound
Primary outcome measures
Preoperative endocrine prognostic index score
Time frame: Up to 5 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Society of Medical Oncology (ESMO) guidelines)
- At the time of screening, histologically confirmed cancers in patients with previously documented activating HER2 mutation (see Appendix A) confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent laboratory.
- Archival tissue availability (if not available a fresh tumor biopsy will be required) and subject must agree to su
Where
- Atlanta, Georgia
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
- Dallas, Texas
- Houston, Texas
Collaborators
National Cancer Institute (NCI), Puma Biotechnology, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations