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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 benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored.
Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety.
Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.
Full 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 who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio.
The efficacy and safety of the two chemotherapy regimens on neoadjuvant chemotherapy for triple-negative breast cancer were evaluated by PCR, EFS, DFS, DDFS and ORR after surgery.
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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:
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
Primary purpose
Allocation
Interventional model
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369 participants in 2 patient groups, including a placebo group
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Central trial contact
Zhenzhen Liu; Dechuang Jiao
Data sourced from clinicaltrials.gov
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