Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.

Sponsor
Fudan University
Study ID
NCT05760378
Phase
PHASE3
Status
Recruiting
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Conditions

  • Triple-Negative Breast Cancer

Eligibility Criteria

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

Interventions

  • Famitinib — DRUG
    TKI
  • Camrelizumab — DRUG
    PD1 inhibitor
  • nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin — DRUG
    TPC

Study Details

The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Key Dates

Start date
Mar 17, 2023
Status verified
Jun 2023
Primary completion
Jan 1, 2025
Completion
Jan 1, 2027

Study Design

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

Arms

  • Experimental: A
    Famitinib in Combination With Camrelizumab and TPC
  • Active Comparator: B
    Combination With Camrelizumab and TPC

Primary Outcome Measure

PFS [ Time Frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years) ]

Central Contacts

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