BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC

Sponsor
Fudan University
Study ID
NCT06793332
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • Triple-Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a single-center, prospective, single-arm clinical trial, which intends to enroll patients with triple-negative breast cancer with brain metastases to receive ivonescimab combined with TROP2 ADC (such as sacituzumab govitecan) treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or the investigator deems it necessary to discontinue the medication, and to collect data on the drug's efficacy and safety.

Key Dates

Start date
Dec 17, 2024
Status verified
Jan 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab combined with TROP2 ADC

Primary Outcome Measure

Intracranial objective response rate (CNS ORR) [ Time Frame: Up to approximately 12 weeks ]

Central Contacts

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