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 (Jun 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
Treatments studied
Targeted therapy
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.
Frequently asked questions
Is NCT06162559 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or IIIA 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