A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases

Conditions

• HER2-negative Breast Cancer Patients With Brain Metastases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Utidelone — DRUG
  Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle.
• Utidelone in combination with capecitabine — DRUG
  UTD1 25 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
• Utidelone in combination with capecitabine — DRUG
  Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
• Utidelone in combination with capecitabine — DRUG
  Utidelone 25 mg/m2/d or 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.

Study Details

This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine. The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.

Key Dates

Start date

Jul 14, 2025

Status verified

Nov 2025

Primary completion

Jan 15, 2027

Completion

Jul 15, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: (stage 1) monotherapy group
• Experimental: (stage 1) combination group A
• Experimental: (stage 1) combination group B
• Experimental: (stage 2) combination group

Primary Outcome Measure

Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria. [ Time Frame: 12 months ]

Central Contacts

• Simon Guan
  +86 10 67864938
  [email protected]

Locations (17)

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