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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 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. The trial reports 5 study locations across 4 states.
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 |
Interested in This 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, categorized as Phase 2. 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 189 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.
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