Cancer Treatment and Pharmacology / Colorectal Cancer Treatments and Studies / Angiogenesis and VEGF in Cancer · Journal article

Benmelstobart plus antiangiogenic therapy vs chemotherapy for metastatic triple-negative breast cancer: phase III trial

npj Breast Cancer · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This open-label, prematurely terminated phase III trial randomized 147 patients with metastatic TNBC to benmelstobart plus anlotinib or nab-paclitaxel monotherapy but failed to meet its primary endpoint of IRC-assessed PFS. Investigator-assessed PFS and overall survival showed numerical trends favoring the combination, but neither reached statistical significance, and the study sponsors explicitly state efficacy analyses are exploratory and require cautious interpretation.

What was studied

Open-label, phase III, 1:1 randomized controlled trial. Patients with recurrent or metastatic triple-negative breast cancer.. Intervention: Benmelstobart plus anlotinib. Compared with: Nab-paclitaxel monotherapy. n = 147.

Key findings

Investigator-assessed median PFS: 7.85 months (combination) vs. 5.55 months (nab-paclitaxel), HR = 0.70 (95% CI 0.46–1.06, P = 0.1687) Median overall survival: 35.81 months (combination) vs. 21.03 months (nab-paclitaxel), HR = 0.78 (95% CI 0.49–1.24, P = 0.2625) Grade ≥3 treatment-related adverse events: 58.7% (combination) vs. 36.6% (monotherapy)

Safety

Grade ≥3 treatment-related adverse events: 58.7% (combination) vs. 36.6% (monotherapy)

Who this may help

This trial provides no statistically significant evidence to support substitution of benmelstobart plus anlotinib for nab-paclitaxel in metastatic TNBC. The increased toxicity (58.7% vs. 36.6% grade ≥3 events) combined with non-significant efficacy trends makes adoption unwarranted pending larger, adequately powered studies.

Plain-language summary

Underpowered trial prematurely stopped at 46% of planned enrollment with non-significant primary endpoint; efficacy analyses explicitly stated as exploratory, requiring cautious interpretation.

Study design

As stated by the source record.

MethodsPatients randomized 1:1 to benmelstobart plus anlotinib or nab-paclitaxel monotherapy, stratified by prior taxane exposure and presence of liver or brain metastases. Enrollment planned for 322 participants but halted prematurely by COVID-19 at 147 randomized (75 experimental, 72 control). Primary endpoint was IRC-assessed progression-free survival. Investigator-assessed PFS and overall survival were also analyzed.

DesignOpen-label, phase III, 1:1 randomized controlled trial

PopulationPatients with recurrent or metastatic triple-negative breast cancer.

Sample size147

InterventionBenmelstobart plus anlotinib

ComparatorNab-paclitaxel monotherapy

Reported figures

Quoted from the source exactly as published.

Sample size147

Planned enrollment322

Median PFS (combination, investigator-assessed)7.85 months

Median PFS (control, investigator-assessed)5.55 months

Hazard ratio PFS0.70

95% CI PFS0.46–1.06

P-value PFS0.1687

Median OS (combination)35.81 months

Clinical bottom line

Caveats

Trial terminated early at 46% of planned enrollment; exploratory efficacy analyses acknowledged by authors and require cautious interpretation
Open-label design; no blinding reported
Primary endpoint (IRC-assessed PFS) not met; reported results are investigator-assessed PFS and OS, not pre-specified primary analysis
Confidence intervals for both PFS and OS cross the null; no absolute risk reductions reported

Evidence assessment

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.

Study design

moderate

Randomized controlled trial with stratification; open-label design limits blinding.

Directness

strong

Directly compares benmelstobart plus anlotinib versus nab-paclitaxel in metastatic TNBC.

Consistency

insufficient

Single trial; no comparative data from other studies provided in source.

Risk of bias

moderate

Open-label design introduces bias; premature termination and underpowering compromise validity.

Sample adequacy

limited

147 participants enrolled versus 322 planned; stopped at 46% due to COVID-19.

Source abstract

This open-label phase III trial assessed a chemotherapy-free regimen for recurrent/metastatic triple-negative breast cancer (TNBC). Patients were 1:1 randomized to benmelstobart plus anlotinib or nab-paclitaxel monotherapy, stratified by prior taxane exposure, liver and brain metastases. Planned enrollment was 322, yet recruitment was prematurely stopped by COVID-19, leaving only 147 randomized participants (75 experimental, 72 control). All efficacy analyses are exploratory and require cautious interpretation. The primary endpoint, IRC-assessed progression-free survival (PFS), was not met. Investigator-assessed median PFS reached 7.85 months for the combination vs. 5.55 months for nab-paclitaxel (HR = 0.70, 95%CI 0.46–1.06, P = 0.1687). Median overall survival (OS) was 35.81 vs. 21.03 months (HR = 0.78, 95%CI 0.49–1.24, P = 0.2625). Grade ≥3 treatment-related adverse events affected 58.7% of combination patients and 36.6% of monotherapy patients. This regimen failed to deliver statistically superior clinical benefits over nab-paclitaxel, only showing a non-significant favorable trend. Further trials are warranted to validate this observation. Trial ID: NCT04405505, registered May 24, 2020 on ClinicalTrials.gov.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Yu RenBinghe XuZhihong WangCancer Treatment and PharmacologyColorectal Cancer Treatments and StudiesJiayu WangQuchang OuyangAngiogenesis and VEGF in CancerQingyuan Zhang