A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04335006
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Carelizumab — DRUG
    Participants receive SHR-1210 intravenously (IV)
  • Nab-paclitaxel — DRUG
    administered intravenously every 4-week cycle
  • Apatinib — DRUG
    administered orally every 4-week cycle

Study Details

This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).

Key Dates

Start date
Jul 14, 2020
Status verified
May 2023
Primary completion
Apr 14, 2023
Completion
Apr 14, 2023

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental A
    Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle
  • Experimental: Experimental B
    Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle
  • Active Comparator: Comparator C
    Subjects receive nab-paclitaxel intravenously each 4-week cycle.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months) ]

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