Status:
RECRUITING
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Early-stage or Locally Advanced HER2-positive Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
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-A18...
Eligibility Criteria
Inclusion
- Females treated for the first time, 18-75 years old;
- ECOG score 0-1;
- Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
- Results of laboratory tests meet the enrollment requirements;
- Pregnancy test result must be negative and must agree to contraception;
- Has signed the informed consent form.
Exclusion
- Confirmed HER2 negative;
- Has tumor-related medical history or treatment history;
- Has severe combined disease/medical history and treatment history;
- Has received treatment with systemic immunostimulants or immunosuppressants;
- Be allergic to the test drug;
- Participate in other clinical trials simultaneously;
- Has received vaccine within 30 days before the first dose;
- Has received allograft bone marrow transplantation;
- Has given birth within one year or is breastfeeding;
- Has history of psychological drug abuse, alcoholism or drug use.
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT07196774
Start Date
October 23 2025
End Date
December 1 2028
Last Update
December 12 2025
Active Locations (2)
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1
Shengjing Hospital, China Medical University
Shenyang, Liaoning, China, 110000
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032