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Neratinib for Breast Cancer
Phase 2
Waitlist Available
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
Study 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.
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.Check my eligibility
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Preoperative endocrine prognostic index score
Secondary outcome measures
Change in Ki67
Incidence of adverse events (NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Pathological complete response rate
+2 moreTrial 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
Mammogram
2016
N/A
~10
Endocrine Therapy
2013
Completed Phase 3
~680
Biospecimen Collection
2004
Completed Phase 2
~1730
Neratinib
2014
Completed Phase 2
~1970
Breast Surgery
2021
Completed Phase 2
~60
Ultrasound
2013
Completed Phase 1
~1950
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,903 Total Patients Enrolled
28 Trials studying Breast Cancer
6,594 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,924,587 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Puma Biotechnology, Inc.Industry Sponsor
56 Previous Clinical Trials
9,762 Total Patients Enrolled
14 Trials studying Breast Cancer
4,397 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or do not want to follow the study's procedures.I can provide previous biopsy samples or agree to a new biopsy for testing.My cancer is estrogen receptor positive.My blood, liver, and kidney functions are all within normal ranges.My cancer does not have the specific HER2 mutations that qualify.My cancer has spread to distant parts of my body.My liver is not working properly.My cancer is confirmed and has a known HER2 mutation.I am 18 years old or older.My cancer has been confirmed to be HER2 positive by specific tests.I have a long-term stomach problem that mainly causes diarrhea.My breast cancer is stage I-III, hormone-receptor positive, and has low or no e-cadherin.I have two breast tumors; both are ER+ and one is HER2-negative.My breast cancer is not driven by estrogen, or is HER2 positive, or needs chemotherapy before surgery.I agree to use effective birth control.I cannot or do not want to take pills.I am fully active or can carry out light work.I have not received any treatment for my current breast cancer diagnosis.I am over 55 years old or meet the hormonal criteria for being postmenopausal.My tumor is at least 1.5 cm big.I have had hormone therapy for breast cancer in the last 2 years.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment A (endocrine therapy)
- Group 2: Treatment B (endocrine therapy, neratinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many venues are offering this research endeavor?
"In total, 8 medical centres are running this trial. These include the University of Pittsburgh Medical Center in Pittsburgh, PA; Vanderbilt University/Ingram Cancer Centre in Nashville, TN; and the University of Texas Southwestern located in Dallas, TX as well as 5 other locations."
Answered by AI
Are any openings available for this trial?
"As per the information displayed on clinicaltrials.gov, this trial is not currently admitting new participants. Initially posted on July 30th 2023 and last modified June 15th 2023 , it appears that no additional candidates are being recruited at present time; however, there exist over 2350 other trials recruiting individuals now."
Answered by AI
Is endocrine therapy coupled with neratinib a safe prescription for patients?
"Treatment B (endocrine therapy, neratinib) was assessed to be safe enough for a score of 2 on the 1-3 scale. This is due to its standing as a Phase 2 trial meaning that while some safety data exists, efficacy has yet to be observed."
Answered by AI
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