OncoMatch/Clinical Trials/NCT05475678
Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
Is NCT05475678 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including （Carrelizumab + TCb） regimen and TCb regimen for breast cancer.
Treatment: （Carrelizumab + TCb） regimen · TCb regimen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative (ihc 0, 1+ without fish, or ihc 2+ with no amplification by fish)
Required: ESR1 negative (ihc nuclear staining <10%)
Required: PR (PGR) negative (ihc nuclear staining <10%)
Disease stage
Required: Stage CT4B, CT4C, CT4D, CT1C WITH AXILLARY LYMPH NODE METASTASIS
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
chemotherapy...have been received
Cannot have received: endocrine therapy
endocrine therapy...have been received
Cannot have received: targeted therapy
targeted therapy...have been received
Cannot have received: radiation therapy
radiation therapy...have been received
Cannot have received: anti-PD-1 therapy
anti-programmed cell death protein 1 (anti-PD-1)...drugs
Cannot have received: anti-PD-L1 therapy
anti-programmed death ligand 1 (anti-PD-L1)...drugs
Cannot have received: anti-PD-L2 therapy
anti-programmed death ligand 2 (anti-PD-L2)...drugs
Cannot have received: immunotherapy
other immunotherapy
Lab requirements
Blood counts
Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy
Kidney function
Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy
Liver function
Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy
Cardiac function
Cardiac ultrasound EF value ≧55%
Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy; Cardiac ultrasound EF value ≧55%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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