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

NCT05919108 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-09

No results posted yet for this 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

  • Anatomic Stage I Breast Cancer
  • Anatomic Stage II Breast Cancer
  • Anatomic Stage III Breast Cancer
  • Invasive Breast Lobular Carcinoma

Interventions

PROCEDURE

Endocrine Therapy

Undergo endocrine therapy

PROCEDURE

Biopsy of breast

Undergo breast biopsy

DRUG

Neratinib

Taken by mouth

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Mammogram

Undergo Mammogram

PROCEDURE

Magnetic Resonance Imaging

Undergo breast Magnetic Resonance Imaging

PROCEDURE

Breast Surgery

Undergo Breast Surgery

PROCEDURE

Ultrasound

Undergo Ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Puma Biotechnology, Inc.

    collaborator INDUSTRY

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Laura Kennedy, MD, PhD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2030-04-30
Completion
2031-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919108 on ClinicalTrials.gov