OncoMatch/Clinical Trials/NCT05638594
Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
Is NCT05638594 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: Pyrotinib · Trastuzumab · Dalpiciclib · Letrozole · Pertuzumab · Docetaxel · Carboplatin · Gonadotropin-releasing hormone agonist — This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1. The experimental group received pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group received trastuzumab combined with pertuzumab, docetaxel and carboplatin. The main study objective was to evaluate the efficacy and safety of neoadjuvant therapy for HR +/HER2 + breast cancer in the two groups.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) positive (positive)
Required: ESR1 positive (positive)
Disease stage
Required: Stage II, III
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
Cannot have received: radiotherapy
Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
Cannot have received: molecular targeted therapy
Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
Cannot have received: endocrine therapy
Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
Lab requirements
Blood counts
anc ≥ 1.5 x 10^9/l; plt ≥ 100 × 10^9/l; hb ≥ 90 g/l
Kidney function
bun and cr ≤ 1.5 × uln and creatinine clearance ≥ 50 ml/min (cockcroft-gault formula)
Liver function
tbil ≤ 1.5 × uln; alt and ast ≤ 3 × uln (≤ 5 × uln in patients with liver metastases)
Cardiac function
lvef ≥ 50%; qt interval ≤ 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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