OncoMatch/Clinical Trials/NCT07351487
Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)
Is NCT07351487 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab for tnbc - triple-negative breast cancer.
Treatment: Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab — 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 treatment of TNBC breast cancer with neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab , including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the event-free survival (EFS), Objective Response Rate(ORR), and radiologic complete response (rCR).
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (ER-negative or <10%)
ER-negative, PR-negative, and HER2 receptor-negative. Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is also classified as TNBC
Required: PR (PGR) negative (PR-negative or <10%)
ER-negative, PR-negative, and HER2 receptor-negative. Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is also classified as TNBC
Required: HER2 (ERBB2) negative (HER2 receptor-negative)
ER-negative, PR-negative, and HER2 receptor-negative. Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is also classified as TNBC
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Pathological examination of PD-L1 expression: The Combined Positive Score (CPS)... Our center detected the PD-L1 antibody site as 22C3.
Disease stage
Required: Stage II, III, T1N1-3, T2-4N0-2
Excluded: Stage IV
Histologically confirmed stage II-III (T1N1-3; T2-4N0-2) 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
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 blood pressure >180mmHg and/or diastolic blood pressure >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, such as atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block). Angina requiring medication for treatment. Heart valve disease with clinical significance. ECG shows transmural myocardial infarction. 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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