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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT05192798 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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