Study of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT04907344
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    IV infusion
  • Nab-Paclitaxel — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion

Study Details

The purpose of this study is to evaluate the efficacy and safety of Camrelizumab in Combination With Nab-Paclitaxel and carboplatin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC).

Key Dates

Start date
Jun 15, 2021
Status verified
May 2021
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

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

Arms

  • Experimental: Part 1: Camrelizumab + Chemotherapy
  • Experimental: Part 2: Camrelizumab + Chemotherapy
  • Active Comparator: Part 2: Chemotherapy

Primary Outcome Measure

pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery [ Time Frame: Up to approximately 24 weeks ]

Central Contacts

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