OncoMatch/Clinical Trials/NCT06162559
Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study
Is NCT06162559 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Tucatinib and Trastuzumab for breast cancer.
Treatment: Tucatinib · Trastuzumab · Pertuzumab — This is a single-center, phase 1b study evaluating the safety and feasibility of a neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab in stage II-IIIA HER2-positive breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
HER2 overexpression defined as circumferential membrane staining that is complete, intense and in >10% of invasive tumor cells (IHC 3+) on pre-treatment biopsy
Required: ESR1 expression (known)
Known estrogen- and progesterone-receptor expression of the invasive tumor
Required: PR (PGR) expression (known)
Known estrogen- and progesterone-receptor expression of the invasive tumor
Disease stage
Required: Stage II, IIIA (TNM-staging (8th edition, AJCC))
Excluded: Stage CN3, CT0
Stage II - IIIA primary breast cancer according to TNM-staging (8th edition, AJCC); (largest tumor diameter on DCE-MRI ≥ 2cm (cT2-3) and/or cN1-2 confirmed with FNA or histology)
Performance status
WHO 0–1
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/l, platelets ≥100 x 10^9/l
Kidney function
creatinine clearance >50 ml/min estimated using the Cockcroft-Gault equation or MDRD equation, or based on a 24-hour urine collection measurement.
Liver function
ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal. Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists.
Cardiac function
LVEF ≥50% measured by echocardiography or MUGA
Adequate bone marrow function (ANC ≥1.5 x 10^9/l, platelets ≥100 x 10^9/l); Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal). Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists. Adequate renal function: creatinine clearance >50 ml/min estimated using the Cockcroft-Gault equation or MDRD equation, or based on a 24-hour urine collection measurement. LVEF ≥50% measured by echocardiography or MUGA
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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