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Utidelone Plus Capecitabine in HER2-negative Breast Cancer With Brain Metastases
NCT06764940Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Jan 2027
- Countries
- 1
- Modality
- Allosteric Modulators
- Drugs
- utidelone
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, open-label trial of utidelone in breast cancer (4 arms), sponsored by Beijing Biostar Pharmaceuticals Co., Ltd. Primary endpoint: Intracranial Objective Response Rate at 12 months. Started Jul 2025; status: recruiting.
02
Design
4 arms- Study design
- RandomizedOpen-label
(stage 1) monotherapy group
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days
(stage 1) combination group A
Utidelone 30 mg/m2/d i.v + capecitabine 1000 mg/m2 orally twice a day
(stage 1) combination group B
UTD1 25 mg/m2/d i.v + capecitabine 1000 mg/m2 orally twice a day
(stage 2) combination group
Utidelone 25 or 30 mg/m2/d i.v + capecitabine 1000 mg/m2 orally twice a day
03
Who it enrols
Adult patients with HER2-negative metastatic breast cancer and at least one measurable intracranial lesion, ECOG PS 0-1, life expectancy >= 3 months, and <= 3 prior lines of chemotherapy.
04
Endpoints
Primary
Intracranial Objective Response Rate
Secondary
Intracranial Objective Response Rate
Objective Response Rate
Progression Free Survival
Disease Control Rate
Duration of Response
Intracranial Progression Free Survival
Intracranial Disease Control Rate
Intracranial Duration of Response
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