OncoMatch/Clinical Trials/NCT05582499
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
Is NCT05582499 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast neoplasm.
Treatment: Dalpiciclib · Pyrotinib · SHR-A1811 · SHR-1316 · Camrelizumab · SHR-A1921 · Pertuzumab · Trastuzumab · Goserelin · Letrozole · Nab paclitaxel · Carboplatin · Epirubicin · Cyclophosphamide · Fluzoparib · Apatinib · Famitinib · HB1801 · LEM · TQB2102 · Benmelstobart · Anlotinib · TQB2868 · Ivonescimab · JS207 · JSKN003 · HRS-4508 · SHR-4602 · paclitaxel — The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression
ER, PR and HER2 status were measured by immunohistochemistry (IHC)
Required: PR (PGR) expression
ER, PR and HER2 status were measured by immunohistochemistry (IHC)
Required: HER2 (ERBB2) expression
ER, PR and HER2 status were measured by immunohistochemistry (IHC)
Disease stage
Required: Stage II (T2N0-1M0/T3N0M0), III (T2N2M0/T3N1-2M0)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Cannot have received: endocrine therapy
Cannot have received: biological therapy
Cannot have received: radiation therapy
Lab requirements
Blood counts
Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL
Kidney function
creatinine < 1 x ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤ 1.5 x ULN, AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
Cardiac function
LVEF≥55%
Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine < 1 x ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); LVEF≥55%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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