Actively Recruiting
Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-01-20
37
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-70 years old
- ECOG performance status score of 0-1
- Histologically confirmed stage II-III invasive breast cancer (T1N1-3; T2-4N0-2)
- Estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2 receptor-negative breast cancer; or ER and PR expression less than 10% with negative HER2
- PD-L1 expression tested with Combined Positive Score (CPS) using 22C3 antibody
- Adequate function of major organs
- Use of effective contraception during treatment and for at least 6 months after last dose if premenopausal or not surgically sterilized
- Willingness to voluntarily join the study, sign informed consent, comply with study procedures, and follow-up
You will not qualify if you...
- Stage IV breast cancer
- Inflammatory breast cancer
- Previous anti-tumor treatment or radiation therapy for malignant tumors, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
- Concurrent anti-tumor treatments in other clinical trials, including chemotherapy, endocrine therapy, biological therapy, bone therapy, or immune checkpoint inhibitors
- Major surgery unrelated to breast cancer within 4 weeks before first study drug dose or incomplete recovery from such surgery
- Serious heart diseases including heart failure with LVEF <50%, uncontrolled arrhythmias, angina requiring medication, significant heart valve disease, myocardial infarction on ECG, or poorly controlled hypertension
- Uncontrolled active infections requiring treatment; immunodeficiency including HIV; history of organ transplantation
- Chronic active hepatitis B or active hepatitis C, except stable or cured cases
- Previous immunotherapy with serious immune-related adverse events affecting safety
- Known allergies to study medication components
- Pregnancy, breastfeeding, positive pregnancy test, or unwillingness to use contraception during and for 6 months after the trial
- Serious comorbidities or other conditions that may interfere with treatment or study participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
2
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
Z
Zhijun Dai
CONTACT
G
Guansheng Zhong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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