OncoMatch/Clinical Trials/NCT06254690

The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study

Is NCT06254690 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pyrotinib dose escalation and Pyrotinib dose normal for breast cancer.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT06254690Data as of May 2026

Treatment: Pyrotinib dose escalation · Pyrotinib dose normal — Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer

Check if I qualify

Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ with FISH+)

HER2-positive expression refers to those with at least one tumor cell immunohistochemical staining intensity of 3+ or 2+ positive by fluorescence in situ hybridization [FISH]

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: HER2 tyrosine kinase inhibitor

Any previous tyrosine kinase inhibitor therapy against HER2 target

Cannot have received: antitumor therapy

Any antitumor therapy within 4 weeks prior to enrollment

Lab requirements

Blood counts

ANC ≥1.5×10^9/L; Platelet ≥100×10^9/L; Hemoglobin ≥9g/dL; Serum albumin ≥3g/dL

Kidney function

Serum creatinine ≤1.5x ULN or creatinine clearance ≥60mL/min

Liver function

Bilirubin ≤1.5 ULN; ALT and AST ≤2.5x ULN; AKP ≤2.5x ULN

Vital organ function meets the following requirements ... Absolute neutrophil (ANC) count ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥9g/dL; Serum albumin ≥3g/dL; Thyroid stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be investigated at the same time, if T3 and T4 levels are normal, they can be included in the group); Bilirubin ≤1.5 ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN; Alkaline phosphatase (AKP) ≤ 2.5 times ULN; Serum creatinine (Cr) ≤1.5 times ULN or creatinine clearance ≥60mL/min.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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