OncoMatch/Clinical Trials/NCT06441890
BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer
Is NCT06441890 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: Paclitaxel · Nab-paclitaxel · Docetaxel · Trastuzumab · Pertuzumab — Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) positive by IHC or FISH according to ASCO/CAP 2018 guidelines
HER2-positive by IHC or FISH according to ASCO/CAP 2018 guidelines
Disease stage
Required: Stage CT1C-T3, CN0-N2 (AJCC)
AJCC clinical stage: cT1c-T3, cN0-N2
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: any therapy for this breast cancer
Any prior therapy for this breast cancer
Lab requirements
Blood counts
Leukocytes ≥2,000/mm3; Platelet count ≥ 75,000/mm3; ANC ≥ 1,000/mm3; Hemoglobin ≥ 9.0 g/dL
Kidney function
Creatinine < 1.5 x ULN or CrCl ≥ 50 mL/min using Cockcroft-Gault formula
Liver function
Bilirubin ≤ 1.5 × ULN (Gilbert's syndrome allowed if no biliary obstruction); AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Cardiac function
Baseline left ventricular ejection fraction (LVEF) of at least 50% on Echo or MUGA scan within 90 days prior to registration.
Leukocytes ≥2,000/mm3 Platelet count ≥ 75,000/mm3 Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 Hemoglobin (Hgb) ≥ 9.0 g/dL Creatinine/Calculated Creatine clearance (CrCI) Cr < 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL/min using the Cockcroft-Gault formula Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin > 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN; Baseline left ventricular ejection fraction (LVEF) of at least 50% on Echo or MUGA scan within 90 days prior to registration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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