Status:
RECRUITING
Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
Lead Sponsor:
Zhenzhen Liu
Conditions:
Breast Cancer
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not be...
Detailed Description
This study mainly compared the efficacy and safety of 6\*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6\*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer. Patients wh...
Eligibility Criteria
Inclusion Criteria:
-
Age: 18-70 years old
-
cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically;
-
Pathologically proven triple negative breast cancer:
Triple-negative breast cancer is defined as:
- Negative for ER and PR (IHC nuclear staining <10%)
- Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH);
-
Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization;
-
Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy;
-
Cardiac ultrasound EF value ≧55%;
-
Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
-
ECOG score≤1 point;
-
Sign informed consent;
Exclusion Criteria:
- The patient has evidence of metastatic breast cancer;
- For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
- The patient has a second primary malignancy other than adequately treated skin cancer;
- The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy;
- The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
- The patient has severe lung or heart disease;
- The patient has active hepatitis B and C;
- The patient has a history of organ transplantation or bone marrow transplantation;
- pregnant or breastfeeding women;
- The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT05475678
Start Date
December 20 2022
End Date
December 31 2029
Last Update
January 23 2025
Active Locations (1)
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1
Henan cancer hospital
Zhengzhou, Henan, China