Actively Recruiting
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-12
30
Participants Needed
11
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）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody, 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 in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-75 years old
- ECOG performance status score of 0-1
- Histologically confirmed invasive HR+/HER2- breast cancer with tumor diameter greater than 1 cm (T1c-3; N0-3; M0)
- PD-L1 expression assessed by Combined Positive Score (CPS) using 22C3 antibody
- Adequate major organ function, including specific blood counts, liver and kidney function, cardiac ultrasound (LVEF >55%), and ECG (QTcF <470 ms)
- Women not yet menopausal or sterilized must use effective contraception during treatment and for 6 months after
- Willingness to provide informed consent and comply with study 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 certain cured cancers
- Concurrent anti-tumor treatment in other clinical trials
- Major surgery unrelated to breast cancer within 4 weeks before study drug administration or incomplete recovery from such surgery
- Serious heart diseases including heart failure (LVEF <50%), uncontrolled arrhythmias, angina requiring medication, significant heart valve disease, recent myocardial infarction, or uncontrolled hypertension
- Active or uncontrolled infections, immunodeficiency including HIV, or 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
- Known allergies to study drugs
- Pregnant or breastfeeding women, women unwilling to use contraception during and 6 months post-treatment
- Serious comorbid diseases or conditions that might interfere with study treatment or participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 11 locations
1
The First Affiliated Hospital of Zhejiang University
Hangzhou, China
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
3
Harbin Medical University Cancer Hospital
Harbin, China
Not Yet Recruiting
4
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Not Yet Recruiting
5
Jinhua Municipal Central Hospital
Jinhua, China
Not Yet Recruiting
6
Nanchang People's Hospital
Nanchang, China
Not Yet Recruiting
7
Zhongshan Hospital, Fudan University
Shanghai, China
Not Yet Recruiting
8
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, China
Not Yet Recruiting
9
Shaanxi Provincial Cancer Hospital
Xi'an, China
Not Yet Recruiting
10
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
11
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Not Yet Recruiting
Research Team
Z
Zhijun Dai
CONTACT
Y
Youyi Chen
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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