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 (Jun 2026). This Phase 2 trial studies multiple treatments including Pyrotinib dose escalation and Pyrotinib dose normal for breast cancer.
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 qualifyExtracted eligibility criteria
Treatments studied
Other
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT06254690 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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 qualifyRelated pages