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

Sponsor
West China Hospital
Study ID
NCT05447702
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Intravenous (IV) infusion
  • Apatinib — DRUG
    po.
  • Nab-paclitaxel — DRUG
    IV infusion.
  • Epirubicin — DRUG
    IV infusion.
  • Cyclophosphamide — DRUG
    IV infusion.

Study Details

The purpose of this study is to evaluate the efficacy and safety of camrelizumab in combination with apatinib and chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC).

Key Dates

Start date
Nov 1, 2022
Status verified
May 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab + Apatinib + Chemotherapy
    Participants received neoadjuvant therapy with four 4-week cycles of camrelizumab (200 mg, q2w) plus apatinib (250 mg, qd) and nab-paclitaxel (125 mg/m2, qw), followed by four 2-week cycles of camrelizumab (200 mg, q2w) plus apatinib (250 mg, qd) and epirubicin (90 mg/m2, q2w) + cyclophosphamide (600 mg/m2, q2w).

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 28 weeks ]

Central Contacts

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