Neoadjuvant Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer

Sponsor
Aiping Shi
Study ID
NCT05088057
Phase
PHASE2
Status
Unknown

Conditions

  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    200mg on Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles (Q3W), intravenous (IV) infusion.
  • Doxorubicin — DRUG
    60mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.
  • Cyclophosphamide — DRUG
    600 mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.
  • Docetaxel — DRUG
    75mg/m² on Day 1 of Cycles 1-4 (Q3W) or Cycles 5-8 (Q3W) of the neoadjuvant phase of the study, IV infusion;

Study Details

The purpose of this study is to evaluate the efficacy and safety of Camrelizumab plus chemotherapy as neoadjuvant therapy and Camrelizumab as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

Key Dates

Start date
Sep 20, 2021
Status verified
Oct 2021
Primary completion
Aug 19, 2024
Completion
Nov 1, 2024

Study Design

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

Arms

  • Experimental: Camrelizumab+Chemotherapy
    PD-1+AC-T: Participants receive Camrelizumab Q3W + doxorubicin Q3W + cyclophosphamide Q3W for 4 cycles, followed by Camrelizumab Q3W + docetaxel Q3W for 4 cycles as neoadjuvant therapy prior to surgery,followed by 9 cycles of Camrelizumab Q3W as adjuvant therapy post-surgery. PD-1+TA: Participants receive Camrelizumab Q3W for 8 cycles , docetaxel Q3W + doxorubicin Q3W for 4 cycles as neoadjuvant therapy prior to surgery,followed by 9 cycles of Camrelizumab Q3W as adjuvant therapy post-surgery.

Primary Outcome Measure

Pathological Complete Response (pCR) [ Time Frame: Up to approximately 12-30 weeks ]

Central Contacts

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