OncoMatch/Clinical Trials/NCT05192798
Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC
Is NCT05192798 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Albumin-Bound Paclitaxel and Apatinib Mesylate for triple-negative breast cancer.
Treatment: Albumin-Bound Paclitaxel · Apatinib Mesylate · Bevacizumab — This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be adjusted appropriately according to the toxic reaction of the patients. Patients in three groups continued to take medication until disease progression/death/toxicity was intolerable/the patient or investigator decided to discontinue the medication. The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR, complete response (CR)+ partial response (PR) + stable disease (SD, \> 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: antitumor systemic therapy
Exception: adjuvant/neoadjuvant therapy completed ≥12 months before randomization; radical radiotherapy completed ≥6 months before randomization
Patients who have not previously received antitumor systemic therapy for the stage of relapse or metastasis; For subjects who have previously undergone adjuvant/neoadjuvant therapy, the time from the end of the last chemotherapy (including taxanes) to randomization should be ≥12 months; The time from the end of radical radiotherapy to randomization should be ≥6 months.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9 / L; Platelet count ≥ 100 x 10^9 / L; Hemoglobin ≥ 90 g/L
Kidney function
Creatinine clearance rate(Ccr) ≥60 mL/min according to the Cockcroft-Gault formula
Liver function
ALT and AST ≤2.5 × ULN; ALT and AST≤5 × ULN if liver metastasis is present
Cardiac function
No recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias; bradycardia (heart rate <50 at rest) or QTcF ≥470 msec excluded
Major organs show good function, and the relevant examination indexes within 7 days prior to randomization meet the following requirements: * Absolute neutrophil count ≥ 1.5 x 10^9 / L; * Platelet count ≥ 100 x 10^9 / L; * Hemoglobin ≥ 90 g/L; * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5 × upper limit of normal (ULN); ALT and AST≤5 × ULN if liver metastasis is present; * Creatinine clearance rate(Ccr) ≥60 mL/min according to the Cockcroft-Gault formula; * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 × ULN, and international normalized ratio (INR)≤1.5 × ULN. ... recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or heart rate-corrected QT interval via Fridericia (QTcF) ≥470 msec.
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