OncoMatch/Clinical Trials/NCT04886531
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
Is NCT04886531 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Neratinib and Letrozole (L) or Anastrozole (A) for breast cancer.
Treatment: Neratinib · Letrozole (L) or Anastrozole (A) · Trastuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification (HER2-positive (by the most recent ASCO-CAP criteria))
HER2-positive (by the most recent ASCO-CAP criteria)
Required: ESR1 positive (ER positive (≥ 10%))
ER positive (≥ 10%)
Disease stage
Required: Stage I, II, III
Excluded: Stage IIIC OR GREATER
Anatomic, clinical stage I-III, invasive breast cancer, greater than 10mm
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: investigational drug
Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is longer.
Lab requirements
Blood counts
Platelet count ≥100,000/uL; ANC ≥1500/uL; Hemoglobin (Hgb) ≥10 g/dL
Kidney function
Calculated creatinine clearance: CrCl ≥30 mL/min using the Cockcroft-Gault formula
Liver function
Bilirubin ≤1.5 x ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by ECHO or MUGA
Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration. LVEF ≥ 50% as assessed by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) documented within 4 weeks prior to the study treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois Cancer Center · Chicago, Illinois
- University of Rochester Medical Center · Rochester, New York
- Penn State Cancer Institute · Hershey, Pennsylvania
- University of Wisconsin · Madison, Wisconsin
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04886531 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify