# Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer

> **NCT07684456** · PHASE3 · NOT_YET_RECRUITING · sponsor: **Beijing Biostar Pharmaceuticals Co., Ltd.** · enrollment: 308 (estimated)

## Conditions studied

- Advanced Breast Cancer

## Interventions

- **DRUG:** Utidelone Capsule
- **DRUG:** Utidelone Injection
- **DRUG:** Capecitabine

## Key facts

- **NCT ID:** NCT07684456
- **Lead sponsor:** Beijing Biostar Pharmaceuticals Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-08-01
- **Primary completion:** 2028-03-01
- **Final completion:** 2029-03-01
- **Target enrollment:** 308 (ESTIMATED)
- **Last updated:** 2026-07-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07684456

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07684456, "Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer". Retrieved via MORVS 2026-10-20 from https://api.morvs.ai/clinical/NCT07684456. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*