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Neratinib for Breast Cancer

Nashville, TN

Phase 2

Recruiting

Led By Laura Kennedy, MD, PhD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if giving neratinib before normal breast cancer therapy can help treat HER2 mutated lobular cancer. It slows/stops cancer cell spread by blocking an abnormal protein that signals cell growth.

See full description

Who is the study for?

This trial is for adults with stage I-III HER2-mutated lobular breast cancer, who haven't had prior treatments. Participants must have a tumor size of at least 1.5 cm, be in good physical condition (ECOG 0 or 1), and agree to use contraception post-treatment. Excluded are those with HER2 amplification, significant liver function issues, known drug hypersensitivity, gastrointestinal disorders causing diarrhea, or any illness that could interfere with the study.

What is being tested?

The trial tests neratinib as an early treatment for patients with specific breast cancer before standard therapy. Neratinib is a kinase inhibitor aiming to slow down cancer by blocking abnormal proteins that encourage cell multiplication. The goal is to see if adding neratinib improves outcomes compared to just endocrine therapy.See study design

What are the potential side effects?

Neratinib may cause side effects like diarrhea, liver problems, rash or dry skin, nausea and vomiting. It can also lead to changes in blood tests related to kidney and liver function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Pathological complete response rate

Rates of breast conservation therapy

Residual cancer burden index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment B (endocrine therapy, neratinib)Experimental Treatment8 Interventions

Patients receive standard of care endocrine therapy and neratinib PO over 4 weeks for 1 cycle. Patients undergo breast tissue biopsy during the lead-in window/cycle 1. Patients then continue endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo breast surgery during weeks 24-25. Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery. Patients undergo mammogram, ultrasound, or breast MRI prior to surgery.

Group II: Treatment A (endocrine therapy)Active Control7 Interventions

Patients receive standard of care endocrine therapy over 4 weeks for 1 cycle. Patients undergo breast tissue biopsy during the lead-in window/cycle 1. Patients then endocrine therapy and neratinib PO daily for 20 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo breast surgery during weeks 24-25. Patients undergo collection of blood samples every 4 weeks while on treatment, at weeks 4 and 24, and at time of surgery. Patients undergo mammogram, ultrasound, or breast MRI prior to surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endocrine Therapy

2019

Completed Phase 3

~680

Neratinib

2014

Completed Phase 2

~1970