Albumin-Bound Paclitaxel / Apatinib Mesylate / Triple Negative Breast Cancer · Phase 2 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a recruiting Phase 2 trial registration with no results yet posted. The study compares albumin-bound paclitaxel monotherapy against two antiangiogenic combinations (apatinib or bevacizumab) in first-line treatment of relapsed/metastatic TNBC, with PFS as the primary endpoint at 2 years. No efficacy or safety data are available from this registry record.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Triple-negative Breast Cancer; Female; age from 18 Years; to 80 Years. Intervention: Group of albumin-bound paclitaxel combined with apatinib; Group of albumin-bound paclitaxel combined with bevacizumab. Compared with: Group of albumin-bound paclitaxel — Active Comparator. n = 128. 1 site: China.
This is a recruiting Phase 2 trial registration with no results yet posted. The study compares albumin-bound paclitaxel monotherapy against two antiangiogenic combinations (apatinib or bevacizumab) in first-line treatment of relapsed/metastatic TNBC, with PFS as the primary endpoint at 2 years. No efficacy or safety data are available from this registry record.
Study is actively recruiting with no results posted; no efficacy or safety data available for clinical decision-making. Secondary outcomes (ORR, CBR, OS, biomarker parameters) and safety endpoints are not yet reported.
The source did not state who this applies to in practice.
This is a recruiting Phase 2 trial with no posted results; it represents planned evidence, not completed evidence, and cannot yet inform clinical practice.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05192798). This is a study registration, not published results. Lead sponsor: The First Affiliated Hospital of Bengbu Medical University. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 128 participants (ESTIMATED). Conditions: Triple-negative Breast Cancer. Interventions: DRUG: Albumin-Bound Paclitaxel; DRUG: Apatinib Mesylate; DRUG: Bevacizumab. Primary outcome measures: Progression-free Survival (PFS) , 2 Years.. Brief summary: 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.
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