OncoMatch/Clinical Trials/NCT05228951
Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC
Is NCT05228951 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pyrotinib maleate, dalpiciclib, Trastuzumab, letrozole for breast cancer.
Treatment: Pyrotinib maleate, dalpiciclib, Trastuzumab, letrozole — NOAH study confirmed that trastuzumab combined with chemotherapy can significantly improve PCR compared with chemotherapy alone, and established the status of trastuzumab as a new adjuvant targeted therapy. The emergence of CDK4/6 inhibitors has brought hope to breast cancer patients resistant to endocrine therapy. studies have shown that pyrotinib maleate combined with CDK4/6 inhibitor can significantly inhibit the proliferation of HER2 positive breast cancer cell lines, reduce the activation of pAKT and pHER3, inhibit cell arrest in G0-G1 phase, and increase cell apoptosis. In the mouse model, pyrotinib maleate combined with CDK4/6 inhibitor exhibits higher anti-tumor activity than any anti-tumor drug alone. Moreover, the toxicity of the combined therapy does not increase compared with monotherapy. This provides a good preclinical model for the treatment of breast cancer by pyrotinib maleate combined with CDK4/6 inhibitor. In addition, NeoALTTO study、CALGB 40601 study、NSABP B-41 study confirmed that the clinical efficacy of lapatinib combined with trastuzumab combined chemotherapy was better than that of lapatinib or trastuzumab single target treatment group. Therefore, it is envisaged that the combination of pyrotinib maleate and dalpiciclib combined with letrozole on the basis of adding new trastuzumab to treat triple positive breast cancer will further improve the curative effect. In conclusion, we believe that pyrotinib maleate combined with trastuzumab, dalpiciclib and letrozole can provide better strategies for neoadjuvant therapy in patients with II-III three positive breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>10% by IHC)
positive estrogen receptor (ER; >10%)
Required: PR (PGR) overexpression (>1% by IHC)
positive progesterone receptor (PR; >1%)
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ and ISH amplification rate ≥2.0)
positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline
Disease stage
Required: Stage II, III
Excluded: Stage IV
Prior therapy
Cannot have received: chemotherapy
Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
Cannot have received: radiotherapy
Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
Cannot have received: molecular targeted therapy
Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
Cannot have received: endocrine therapy
Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
Cannot have received: other anti-tumor drug treatments concurrently
Those who have received other anti-tumor drug treatments concurrently
Lab requirements
Blood counts
ANC ≥1.5×10^9/L (no use of growth factor within 14 days); Platelet count ≥100×10^9/L (no corrective treatment within 7 days); Hemoglobin ≥100 g/L (no corrective treatment within 7 days)
Kidney function
Blood urea nitrogen and creatinine ≤1.5x ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤1.5x ULN; ALT and AST ≤3x ULN
Cardiac function
Left ventricular ejection fraction ≥50%; QTc interval ≤480 ms
The functional level of organs must meet the following requirements: ... see full criteria
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