Actively Recruiting
Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-01-14
35
Participants Needed
13
Research Sites
259 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 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)
CONDITIONS
Official Title
Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-70 years old
- ECOG score of 0-1 points
- Histologically confirmed invasive breast cancer tumors larger than 1cm (T1c-3; N0-2; M0)
- Confirmed triple-negative breast cancer by histopathology
- Pathological examination of PD-L1 expression using the 22C3 antibody site and Combined Positive Score (CPS)
- Functional level of major organs meets study requirements
- For premenopausal or non-surgically sterilized females: effective contraception during treatment and for 6 months after last administration
- Voluntary participation with signed informed consent, good compliance, and willingness to follow-up
You will not qualify if you...
- Stage IV breast cancer
- Inflammatory breast cancer
- Prior anti-tumor treatment or radiation for any malignant tumor except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
- Concurrent anti-tumor treatment in other clinical trials including chemotherapy, endocrine therapy, biological therapy, bone improvement drugs, or immune checkpoint inhibitors
- Major surgery unrelated to breast cancer within 4 weeks before first study drug administration or not fully recovered from such surgery
- Serious heart diseases including heart failure or systolic dysfunction (LVEF < 50%), uncontrolled arrhythmias, angina requiring medication, significant heart valve disease, transmural myocardial infarction on ECG, or poorly controlled hypertension
- Uncontrolled active infections needing treatment; history of immunodeficiency including HIV or organ transplantation
- Chronic active hepatitis B or active hepatitis C (excluding stable or cured cases)
- Previous immunotherapy with adverse immune events affecting safety
- Known allergies to study medication components
- Pregnant, lactating, or positive pregnancy test or unwilling to use effective contraception during and 6 months after study
- Serious comorbidities or conditions interfering with planned treatment or deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Nanchang People's Hospital
Nanchang, Jiangxi, China
Not Yet Recruiting
2
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Actively Recruiting
3
The First Affiliated Hospital of Zhejiang University
Hangzhou, China
Actively Recruiting
4
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
5
Harbin Medical University Cancer Hospital
Harbin, China
Not Yet Recruiting
6
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
7
Jinhua Municipal Central Hospital
Jinhua, China
Actively Recruiting
8
Nantong First People's Hospital
Nantong, China
Actively Recruiting
9
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
10
Shanxi Provincial Cancer Hospital
Shanxi, China
Not Yet Recruiting
11
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Not Yet Recruiting
12
Xinjiang Medical University Affiliated Cancer Hospital
Xinjiang, China
Not Yet Recruiting
13
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 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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