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 (May 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
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 →
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