Actively Recruiting
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
Led by Ruth O'Regan · Updated on 2026-04-08
30
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
Sponsors
R
Ruth O'Regan
Lead Sponsor
P
Puma Biotechnology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.
CONDITIONS
Official Title
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA authorization
- Age 18 years or older
- Postmenopausal female defined by age, oophorectomy, or estradiol levels
- ECOG Performance Status 0 to 2
- Invasive breast cancer, clinical stage I-III, tumor larger than 10 mm
- HER2-positive breast cancer by current criteria
- Estrogen receptor positive (at least 10%)
- Resectable breast cancer suitable for pre-operative therapy
- Archival tissue from diagnostic biopsy available
- Willing to undergo repeat breast biopsy at 3 weeks
- Candidate for letrozole or anastrozole treatment
- Left ventricular ejection fraction (LVEF) 50% or higher
- Adequate blood counts, kidney and liver function
- HIV patients with undetectable viral load on therapy eligible
- Hepatitis B or C patients must have undetectable viral load or cured
- Ability to understand and comply with study requirements
You will not qualify if you...
- Locally advanced or inflammatory breast cancer (Stage IIIC or higher)
- Evidence of metastatic disease
- Prior or concurrent cancer that may interfere with study except certain skin and in situ cancers disease-free for 5 years
- Active infection requiring systemic therapy
- Need for moderate or strong CYP3A4 inhibitors or inducers during study
- Use of investigational drugs within 14 days or 5 half-lives
- Major surgery within 14 days or not recovered from major surgery
- Gastrointestinal disorders affecting drug absorption or swallowing
- History of myelodysplastic syndrome or acute myeloid leukemia
- Abdominal fistula, GI perforation, or abscess within 28 days
- Stroke or transient ischemic attack within 12 months
- Recent acute coronary syndromes or symptomatic pericarditis within 6 months
- Symptomatic heart failure or cardiomyopathy with LVEF below 50%
- Clinically significant ventricular arrhythmias or high-grade AV block without pacemaker
- Long QT syndrome or family history of sudden death or congenital long QT
- Severe or uncontrolled medical conditions posing safety risks or interfering with study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
2
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
3
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
4
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
R
Ruth O'Regan, MD
CONTACT
A
Amber Ryba
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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