A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
NCT ID: NCT07196774
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
740 participants
INTERVENTIONAL
2025-10-23
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SHR-A1811 Group
SHR-A1811 for Injection
SHR-A1811 for injection.
Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group
Docetaxel injection
Docetaxel injection.
Trastuzumab Injection
Trastuzumab injection.
Carboplatin for Injection
Carboplatin for injection.
Pertuzumab Injection
Pertuzumab injection.
Interventions
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SHR-A1811 for Injection
SHR-A1811 for injection.
Docetaxel injection
Docetaxel injection.
Trastuzumab Injection
Trastuzumab injection.
Carboplatin for Injection
Carboplatin for injection.
Pertuzumab Injection
Pertuzumab injection.
Eligibility Criteria
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Inclusion Criteria
2. ECOG score 0-1;
3. Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
4. Results of laboratory tests meet the enrollment requirements;
5. Pregnancy test result must be negative and must agree to contraception;
6. Has signed the informed consent form.
Exclusion Criteria
2. Has tumor-related medical history or treatment history;
3. Has severe combined disease/medical history and treatment history;
4. Has received treatment with systemic immunostimulants or immunosuppressants;
5. Be allergic to the test drug;
6. Participate in other clinical trials simultaneously;
7. Has received vaccine within 30 days before the first dose;
8. Has received allograft bone marrow transplantation;
9. Has given birth within one year or is breastfeeding;
10. Has history of psychological drug abuse, alcoholism or drug use.
18 Years
75 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shengjing Hospital, China Medical University
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-A1811-312
Identifier Type: -
Identifier Source: org_study_id
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