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NCT05919108 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
A Phase 2 study of Anatomic Stage I Breast Cancer and Anatomic Stage II Breast Cancer, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT05919108: Recruiting Phase 2 study of Anatomic Stage I Breast Cancer and Anatomic Stage II Breast Cancer, sponsored by Vanderbilt-Ingram Cancer Center.
NCT05919108 is a Phase 2 study of Anatomic Stage I Breast Cancer and Anatomic Stage II Breast Cancer that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05919108, a Phase 2 study of Anatomic Stage I Breast Cancer and Anatomic Stage II Breast Cancer, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
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 |
What NCT05919108 shows while recruiting
NCT05919108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
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.
NCT05919108 lists 5 locations in 4 states (Texas, Georgia, Pennsylvania).
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.
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).
Who is sponsoring clinical trial NCT05919108?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
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 this trial's enrollment target compares
Where NCT05919108's enrollment target sits among peer trials
30 1582nd of 2000 higher than 333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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