Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
NCT05919108 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Endocrine Therapy
- PROCEDURE Biopsy of breast
- DRUG Neratinib
- PROCEDURE Mammogram
Study Locations (5)
Texas
- University of Texas, Southwestern — Dallas
- Baylor College of Medicine — Houston
Georgia
- Emory University/ Winship Cancer Institute — Atlanta
Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh
Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-30 |
| Est. Completion | 2031-04-30 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05919108
The ClinicalTrials.gov registry entry for NCT05919108 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Anatomic Stage I Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05919108 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Texas, Georgia, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05919108 about?
NCT05919108 is a clinical study titled "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 sign...
What is the current status of trial NCT05919108?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-05-30. Estimated completion is 2031-04-30.
What conditions does trial NCT05919108 study?
This clinical trial studies the following conditions: Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05919108?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Endocrine Therapy (PROCEDURE), Biopsy of breast (PROCEDURE), Neratinib (DRUG), Mammogram (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05919108?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05919108 being conducted?
This trial has 5 study locations across Georgia, Pennsylvania, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.