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Clinical trialNCT05919108RecruitingPhase 2Interventional

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

SponsorVanderbilt-Ingram Cancer CenterEnrollment30Anatomic Stage I Breast CancerAnatomic Stage II Breast CancerAnatomic Stage III Breast CancerInvasive Breast Lobular Carcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Emory University/ Winship Cancer Institute

    Atlanta, Georgia, United States

    Kevin Kalinsky, MD
    Not, yet, recruiting
  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, United States

    Adam Brufsky, MD
    Not, yet, recruiting
  • Vanderbilt University/ingram Cancer Center

    Nashville, Tennessee, United States

    Laura Kennedy, MD, PhD
    Recruiting
  • University of Texas, Southwestern

    Dallas, Texas, United States

    Carlos Arteaga, MDNisha Unni, MD
    Recruiting
  • Baylor College of Medicine

    Houston, Texas, United States

    Bora Lim, MD
    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Neratinib →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 Jun 2024
Primary completion
30 Apr 2030
Completion
30 Apr 2031
Last update posted
19 Aug 2026
Registered enrollment
30
Registry id
NCT05919108
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.