Actively Recruiting
Neoadjuvant Chemotherapy Combined With Toripalimab for Triple-negative Breast Cancer a Prospective Single-arm Multi-center Study (NEOTORCH-BREAST02)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-01-14
35
Participants Needed
13
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Toripalimab combined with neoadjuvant chemotherapy as an adjuvant treatment for triple-negative breast cancer (TNBC). This phase II, prospective, single-arm, multi-center clinical trial aims to assess the pathologic complete response (PCR) rate along with the types and frequency of side effects. Secondary objectives include monitoring disease-free survival, progression-free survival, and objective response rate in participants. The treatment involves two phases of neoadjuvant chemotherapy combined with Toripalimab administered intravenously every three weeks. The first phase includes Epirubicin, Cyclophosphamide, and Toripalimab for six weeks, followed by Albumin-bound Paclitaxel plus Toripalimab for another six weeks. After four treatment cycles, participants undergo radical breast cancer surgery. Postoperative therapy depends on pathology results: if PCR is achieved, immunotherapy with Toripalimab continues every three weeks for one year; if not, chemotherapy combined with Toripalimab continues. Gene testing on biopsy tissue and blood samples for ctDNA testing are also performed before and after treatment. During the study, participants will have regular assessments including pathology evaluation and monitoring of side effects. Researchers will track treatment response and survival outcomes over two to three years. The total involvement includes neoadjuvant treatment, surgery, postoperative therapy, and follow-up to evaluate treatment effectiveness and safety. Careful monitoring ensures adherence and collection of important biological samples for ongoing analysis.
CONDITIONS
Brief 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 performance status score of 0-1
- Histologically confirmed invasive breast cancer tumors larger than 1 cm (T1c-3; N0-2; M0)
- Confirmed triple-negative breast cancer by histopathology
- Pathological examination of PD-L1 expression with Combined Positive Score using 22C3 antibody
- Functional major organs meeting study requirements
- Effective contraceptive use for at least 6 months after last treatment for women not menopausal or sterilized
- Voluntary informed consent and willingness to comply with study and follow-up procedures
You will not qualify if you...
- Stage IV breast cancer
- Inflammatory breast cancer
- Previous anti-tumor treatment or radiation for any malignant tumor, except cured cervical carcinoma in situ or certain skin cancers
- Participation in other anti-tumor clinical trials or treatments
- Major surgery unrelated to breast cancer within 4 weeks prior to study drug administration or incomplete recovery
- Serious heart disease including heart failure, uncontrolled arrhythmias, angina requiring medication, significant heart valve disease, myocardial infarction, or poorly controlled hypertension
- Uncontrolled active infections or immunodeficiency, including HIV or organ transplant history
- Chronic active hepatitis B or active hepatitis C, except stable or cured cases
- Prior immunotherapy causing serious immune-related adverse events
- Known allergies to study medication components
- Pregnant or lactating women, or women unwilling to use effective contraception during and 6 months after treatment
- Serious accompanying diseases or other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants receive gene testing on biopsy tissue and have blood samples collected for ctDNA testing before starting treatment.
1 visit (in-person)
Duration - Approximately 18 weeks
Participants receive neoadjuvant chemotherapy combined with Toripalimab in two phases, followed by breast cancer radical surgery and postoperative adjuvant therapy based on pathology results.
4 chemotherapy cycles over 12 weeks with intravenous infusions every 3 weeks, 1 surgery visit, and postoperative treatment visits as per pathology results
Duration - Up to 1 year
Participants continue with immunotherapy or adjuvant chemotherapy combined with Toripalimab after surgery depending on pathology, with ongoing monitoring for up to 1 year.
Infusions every 3 weeks, frequency depending on postoperative treatment plan
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
G
Guansheng Zhong
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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