OncoMatch/Clinical Trials/NCT05919108
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Is NCT05919108 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Neratinib for anatomic stage i breast cancer.
Treatment: Neratinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) activating mutation
histologically confirmed cancers in patients with previously documented activating HER2 mutation (see Appendix A) confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent laboratory
Required: ESR1 expression ≥1% estrogen receptor (ER) positive (≥1%)
ER+ disease defined as ≥1% estrogen receptor (ER) positive
Excluded: HER2 (ERBB2) amplification
HER2 amplification by FISH (HER2:CEP17 ratio >2.0) or IHC (HER2 (3+))
Excluded: HER2 (ERBB2) ineligible somatic HER2 mutations, such as those that are subclonal in nature or those resulting in the expression of truncated proteins including alterations that result in premature stop codon or a change in reading frame (ie, frame shift mutations)
Patients harboring ineligible somatic HER2 mutations, such as those that are subclonal in nature or those resulting in the expression of truncated proteins including alterations that result in premature stop codon or a change in reading frame (ie, frame shift mutations).
Disease stage
Required: Stage I, II, III (anatomic)
Excluded: Stage DISTANT METASTATIC DISEASE
clinical stage I-III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: endocrine therapy
Prior endocrine therapy for breast cancer within the last 2 years
Cannot have received: investigational treatment
Any investigational treatment for the current diagnosis of breast cancer
Lab requirements
Blood counts
ANC ≥1500/mm^3; Platelet count ≥100,000/mm^3; HgB ≥ 9 g/dL
Kidney function
Estimated glomerular filtration rate of ≥50 mL/min; Albumin ≥ 2.5 g/dL
Liver function
AST and ALT ≤ 3 x ULN; Total serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN with Gilbert Syndrome, direct bilirubin ≤ 1.5 x ULN)
Patients must have adequate hematologic, hepatic, and renal function. All laboratory tests must be obtained within 1 month of study entry. This includes: Estimated glomerular filtration rate of ≥50 mL/min; Albumin ≥ 2.5 g/dL; ANC ≥1500/mm^3; Platelet count ≥100,000/mm^3; HgB ≥ 9 g/dL; Total serum bilirubin ≤ 1.5 x ULN (in patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN); AST and ALT ≤ 3 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University/ Winship Cancer Institute · Atlanta, Georgia
- University of Pittsburgh Medical Center · Pittsburgh, Pennsylvania
- Vanderbilt University/Ingram Cancer Center · Nashville, Tennessee
- University of Texas, Southwestern · Dallas, Texas
- Baylor College of Medicine · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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