HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer

Sponsor
Fudan University
Study ID
NCT06849492
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Triple Negative Breast Cancer

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    PD-1 inhibitor
  • Nab-paclitaxel — DRUG
    chemotherapy
  • SKB264 — DRUG
    Trop2-ADC
  • Lenvatinib — DRUG
    Anti-angiogenic TKI

Study Details

To explore the efficacy and safety of treatment for recurrent and metastatic advanced first-line triple-negative breast cancer guided by cell surface protein-based subtyping (HIM).

Key Dates

Start date
Apr 1, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Cohort A (H subtyping)
  • Experimental: Cohort B (I subtyping)
  • Experimental: Cohort C (M subtyping)

Primary Outcome Measure

ORR [ Time Frame: at the time point of every 12 weeks, up to one year ]

Central Contacts

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