RecruitingPhase 2NCT05919108

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


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

30 participants

Start Date

May 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted drug called neratinib given before surgery (neoadjuvant therapy) in patients with early-stage hormone receptor-positive lobular breast cancer that carries a specific HER2 gene mutation. Lobular breast cancer is a type that grows in a different pattern than the more common ductal breast cancer, and this trial focuses on cases where a HER2 mutation (not amplification) is driving tumor growth. **You may be eligible if:** - You are 18 years or older - You have been newly diagnosed with early-stage (stage I–III) hormone receptor-positive lobular breast cancer confirmed by biopsy - Your tumor has a confirmed HER2-activating mutation (not just HER2 amplification) detected by a certified lab - Your tumor is at least 1.5 cm in size - You are in good physical health (ECOG 0–1) with adequate blood, kidney, and liver function - You have not yet received treatment for this cancer **You may NOT be eligible if:** - Your cancer has spread to distant parts of the body (metastatic) - Your tumor does not have a confirmed HER2-activating mutation - Your tumor is HER2-amplified (IHC 3+ or FISH positive) rather than HER2-mutated - Your organ function does not meet the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndocrine Therapy

Undergo endocrine therapy

PROCEDUREBiopsy of breast

Undergo breast biopsy

DRUGNeratinib

Taken by mouth

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREMammogram

Undergo Mammogram

PROCEDUREMagnetic Resonance Imaging

Undergo breast Magnetic Resonance Imaging

PROCEDUREBreast Surgery

Undergo Breast Surgery

PROCEDUREUltrasound

Undergo Ultrasound


Locations(5)

Emory University/ Winship Cancer Institute

Atlanta, Georgia, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

University of Texas, Southwestern

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05919108