OncoMatch/Clinical Trials/NCT06682195
Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)
Is NCT06682195 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Neoadjuvant chemotherapy combined with Toripalimab for tnbc, triple negative breast cancer.
Treatment: Neoadjuvant chemotherapy combined with Toripalimab — This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR） of Adjuvant treatment of TNBC breast cancer with Toripalimab combined with neoadjuvant chemotherapy, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression testing required (testing required; no eligibility threshold specified)
Pathological examination of PD-L1 expression: The Combined Positive Score (CPS)...detected the PD-L1 antibody site as 22C3.
Disease stage
Required: Stage T1C-3, N0-2
Excluded: Stage IV
tumors >1cm in diameter (T1c-3; N0-2; M0) invasive breast cancer; Stage IV breast cancer [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor treatment
Exception: excluding those that have been cured malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.
Cannot have received: anti-tumor treatment in other clinical trials
Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.
Lab requirements
Blood counts
The functional level of major organs must meet requirements
Kidney function
The functional level of major organs must meet requirements
Liver function
The functional level of major organs must meet requirements
Cardiac function
No serious heart disease or discomfort, including but not limited to: diagnosed history of heart failure or systolic dysfunction (LVEF <50%), high risk uncontrolled arrhythmias, angina requiring medication, heart valve disease with clinical significance, ECG shows transmural myocardial infarction, poor control of hypertension (systolic BP >180mmHg and/or diastolic BP >100mmHg after drug treatment)
The functional level of major organs must meet requirements; Serious heart disease or discomfort, including but not limited to the following diseases: Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%). High risk uncontrolled arrhythmias... Poor control of hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 100mmHg after drug treatment)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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