Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

Sponsor
Henan Cancer Hospital
Study ID
NCT05769010
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1811 — DRUG
    SHR-A1811: intravenous
  • Pyrotinib — DRUG
    Pyrotinib: oral
  • Bevacizumab — DRUG
    Bevacizumab: intravenous
  • Adebelizumab — DRUG
    Adebelizumab: intravenous

Study Details

This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.

Key Dates

First listed
Mar 15, 2023
Start date
Mar 31, 2023
Status verified
Mar 2026
Primary completion
Dec 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    HER2-positive: SHR-A1811
  • Experimental: Arm 2
    HER2-positive: SHR-A1811 and pyrotinib
  • Experimental: Arm 3
    HER2-positive: SHR-A1811 and bevacizumab
  • Experimental: Arm 4
    HER2-low: SHR-A1811
  • Experimental: Arm 5
    HER2-low: SHR-A1811 and bevacizumab
  • Experimental: Arm 6
    HER2-low: SHR-A1811 and Adebelizumab

Primary Outcome Measure

CNS-ORR by investigator [ Time Frame: 2 months ]

Central Contacts

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