Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

Sponsor
Henan Cancer Hospital
Study ID
NCT07100600
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • HER2-positive Advanced Breast Cancer
  • Radiotherapy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Rezetecan — DRUG
    Trastuzumab Rezetecan：4.8mg/kg Q3W
  • FSRT or WBRT — RADIATION
    FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

Study Details

A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).

Key Dates

First listed
Aug 3, 2025
Start date
Aug 30, 2025
Status verified
Aug 2025
Primary completion
Jul 30, 2030
Completion
Dec 30, 2032

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: control group
    Trastuzumab Rezetecan
  • Experimental: experimental group
    Trastuzumab Rezetecan combined with radiotherapy

Primary Outcome Measure

PFS [ Time Frame: up to 1.5 years ]

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