Actively Recruiting
Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-03
111
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, multi-cohort, multicenter, open-label exploratory clinical trial. The primary study objective is to evaluate the pathologic complete response (PCR) of treatment of HR+/HER2-low breast cancer with neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab , including the incidences and types of adverse events. The secondary endpoints include event-free survival (EFS), residual cancer burden (RCB), and objective response rate (ORR).
CONDITIONS
Official Title
Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-70 years old
- ECOG performance status of 0 or 1
- Histologically or pathologically confirmed invasive breast cancer staged T1cN1-2M0 or T2-3N0-2M0
- Breast cancer must be HR-positive and HER2-low as defined by 2020 and 2023 ASCO/CAP Guidelines
- Function of major organs meets required criteria
- For females not menopausal or surgically sterilized: use effective contraception during treatment and for 6 months after last dose
- Willing to voluntarily join the study, sign informed consent, comply with study procedures, and agree to follow-up
You will not qualify if you...
- Stage IV breast cancer
- Inflammatory breast cancer
- Prior anti-tumor treatment or radiation therapy for any malignant tumor except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
- Currently receiving anti-tumor treatment in other clinical trials
- Major surgery unrelated to breast cancer within 4 weeks prior to first study drug dose or not fully recovered from such surgery
- Serious heart disease or discomfort
- Uncontrolled active infections requiring treatment
- History of immunodeficiency or organ transplantation
- Chronic active hepatitis B or active hepatitis C
- Prior immunotherapy with immune-related adverse events like pneumonia or myocarditis that may affect study drug safety
- Known allergy to components of the treatment regimen
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Harbin Medical University Cancer Hospital
Harbin, China
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
3
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
4
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
5
The Second Affiliated Hospital of Xi'an Jiaotong University
Zhengzhou, China
Actively Recruiting
Research Team
Z
Zhijun Dai
CONTACT
W
Wanting Shao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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