Actively Recruiting
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Led by Vanderbilt-Ingram Cancer Center · Updated on 2025-09-09
30
Participants Needed
5
Research Sites
360 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- New diagnosis of clinical stage I-III hormone receptor positive invasive lobular carcinoma confirmed by histology
- Synchronous breast tumors allowed if estrogen receptor positive and HER2-negative
- Estrogen receptor positive disease defined as at least 1% positive by ASCO/CAP or ESMO guidelines
- Histologically confirmed activating HER2 mutation verified by a certified laboratory
- Archival tissue available or willingness to provide fresh tumor biopsy for central testing
- Minimum tumor size of 1.5 cm or larger by imaging or clinical exam
- ECOG performance status 0 or 1
- Adequate blood, liver, and kidney function based on lab tests within 1 month prior to study entry
- Pre-, peri-, or post-menopausal status confirmed by history or lab tests
- Diagnostic biopsy tissue available with sufficient tumor for next-generation sequencing
- No prior treatment for current breast cancer diagnosis
- Agreement to use effective contraception during treatment and for 30 days after last dose if of childbearing potential
You will not qualify if you...
- Evidence of distant metastatic disease
- Synchronous breast cancer that is estrogen receptor negative, HER2-amplified, or requiring neoadjuvant chemotherapy
- Presence of ineligible somatic HER2 mutations such as subclonal or truncated protein mutations
- Prior endocrine therapy for breast cancer within the last 2 years
- Pregnancy, planning pregnancy, or breastfeeding
- Current investigational treatment for breast cancer
- HER2 amplification by FISH or IHC (3+)
- Impaired liver function with AST or ALT over 3 times the upper limit or elevated bilirubin beyond specified limits
- Significant chronic gastrointestinal disorders with major diarrhea symptoms
- Significant medical, psychiatric, or social issues that may interfere with study participation
- Known allergy to study drugs or loperamide
- Unable or unwilling to swallow tablets
- Unable or unwilling to complete required study procedures including biopsies or imaging
- Any medical condition judged by investigators to impair ability to complete study therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Emory University/ Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
3
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
University of Texas, Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
5
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
V
Vanderbilt-Ingram Services for Timely Access
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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