Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy for Triple-Negative Breast Cancer
A Single-Arm, Phase II Clinical Study of Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy in Patients With Early or Locally Advanced Triple-Negative Breast Cancer
Sponsor: Fudan University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
pathological complete response rate (pCR)
Time frame: Up to approximately 24 weeks
Secondary Endpoints
Event-free Survival (EFS) as assessed by Investigator
Disease-free Survival (DFS) as assessed by Investigator
Distant Disease-free Survival (DDFS) as assessed by Investigator
Eligibility Criteria
Inclusion Criteria: * 1\. Age 18 to 75 years old, female. 2\. Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of clinical stage II （T1cN1M0/T2N0-1M0/T3N0M0）or stage III (T1cN2-N3M0/T2N2-3M0/T3N1-3M0）. 3\. Patients with Triple Negative breast cancer. 4\. According to the RECIST 1.1 criteria, there is at least one measurable objective lesion. 5\. Eastern Cooperative Oncology Group (ECOG) performance score 0-1. 6\. Appropriate haematological, hepatic and renal function : 1) Absolute number of neutrophils (ANC) ≥ 1.5 x 10\^9/L; 2) Platelets ≥ 100 x 10\^9/L; 3) Hemoglobin ≥ 90 g/L ; 4) White blood cell (WBC) ≥ 3.0×10\^9/L and ≤15×10\^9/L; 5) Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 6) AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; 7) serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance (CrCL) ≥50 mL/min (Cockcroft-Gault equation); 8) Prothrombin time (PT) and activated partial thromboplastin time (…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →