Actively Recruiting
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-01-30
740
Participants Needed
2
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.
CONDITIONS
Official Title
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- First-time treatment for breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Pathological confirmation of HER2-positive breast cancer
- Laboratory test results meeting study requirements
- Negative pregnancy test and agreement to use contraception
- Signed informed consent form
You will not qualify if you...
- HER2-negative breast cancer
- Previous tumor-related medical history or treatment
- Severe combined diseases or medical history
- Prior treatment with systemic immunostimulants or immunosuppressants
- Allergy to the study drug
- Participation in other clinical trials simultaneously
- Vaccination within 30 days before the first dose
- History of allogeneic bone marrow transplantation
- Gave birth within one year or currently breastfeeding
- History of psychological drug abuse, alcoholism, or drug use
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Shengjing Hospital, China Medical University
Shenyang, Liaoning, China, 110000
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Yang Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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