Who is sponsoring NCT05919108?

NCT05919108 is sponsored by Vanderbilt-Ingram Cancer Center.

What drugs are being tested in NCT05919108?

Interventions in NCT05919108: Endocrine Therapy, Biopsy of breast, Neratinib, Biospecimen Collection, Mammogram, Magnetic Resonance Imaging, Breast Surgery, Ultrasound.

What condition does NCT05919108 study?

NCT05919108 studies Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma.

Is NCT05919108 still recruiting?

NCT05919108 is currently recruiting now. Last updated 9 September 2025.

Last reviewed 2025-09-09 · How we verify

NCT05919108

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

Recruiting now Phase 2 Last updated 9 September 2025

What this trial tests

Phase 2 trial testing Endocrine Therapy in Anatomic Stage I Breast Cancer in 30 participants. Currently enrolling.

Timeline

30 May 2024

Primary endpoint
30 April 2030

30 April 2031

Quick facts

Lead sponsor	Vanderbilt-Ingram Cancer Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	30 May 2024
Primary completion	30 April 2030
Estimated completion	30 April 2031
Sites	5 locations across United States

Drugs / interventions tested

Endocrine Therapy (endocrine-therapy) — full drug profile →
Biopsy of breast
Neratinib — full drug profile →
Biospecimen Collection — full drug profile →
Mammogram
Magnetic Resonance Imaging
Breast Surgery
Ultrasound

Conditions studied

Anatomic Stage I Breast Cancer — all drugs for Anatomic Stage I Breast Cancer →
Anatomic Stage II Breast Cancer — all drugs for Anatomic Stage II Breast Cancer →
Anatomic Stage III Breast Cancer — all drugs for Anatomic Stage III Breast Cancer →
Invasive Breast Lobular Carcinoma — all drugs for Invasive Breast Lobular Carcinoma →

Sponsor

Vanderbilt-Ingram Cancer Center — full company profile →

Who can join

18 and older, any sex, with Anatomic Stage I Breast Cancer or Anatomic Stage II Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Molecular Insights on Signaling Cascades in Breast Cancer: A Comprehensive Review.
Panda VK, Mishra B, Mahapatra S, Swain B, et al · · 2025 · cited 17× · PMID 39858015 · DOI 10.3390/cancers17020234
Novel HER-2 Targeted Therapies in Breast Cancer.
Fernandes CL, Silva DJ, Mesquita A. · · 2023 · cited 9× · PMID 38201515 · DOI 10.3390/cancers16010087
HER2 mutation as an emerging target in advanced breast cancer.
Bon G, Di Lisa FS, Filomeno L, Arcuri T, et al · · 2024 · cited 7× · PMID 38715247 · DOI 10.1111/cas.16148
Unique Molecular Alteration of Lobular Breast Cancer: Association with Pathological Classification, Tumor Biology and Behavior, and Clinical Management.
Zhang H, Peng Y. · · 2025 · cited 5× · PMID 39941785 · DOI 10.3390/cancers17030417

Verify or expand the search:

Other trials of Endocrine Therapy

Trials testing the same drug.

NCT05411380 — Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast · Phase 2 · unknown
NCT04109066 — Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Partici · Phase 3 · completed

Other Vanderbilt-Ingram Cancer Center trials

Trials by the same sponsor.

NCT06638398 — Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules · NA · active not recruiting
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NCT06105801 — EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing · Phase 4 · recruiting
NCT06399640 — Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06016855 — Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroend · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05919108 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center
Last refreshed: 9 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05919108.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing