A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
NCT ID: NCT06057610
Last Updated: 2025-04-20
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
864 participants
INTERVENTIONAL
2023-10-16
2032-10-31
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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Treatment group A: SHR-A1811 Injection
SHR-A1811 Injection
SHR-A1811 Injection
Treatment group B: SHR-A1811 Injection and Pertuzumab Injection
SHR-A1811 Injection ； Pertuzumab Injection
SHR-A1811 Injection ； Pertuzumab Injection
Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection
Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
Interventions
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SHR-A1811 Injection
SHR-A1811 Injection
SHR-A1811 Injection ； Pertuzumab Injection
SHR-A1811 Injection ； Pertuzumab Injection
Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
Eligibility Criteria
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Inclusion Criteria
2. HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
3. ECOG score is 0 or 1
4. An expected survival of ≥ 12 weeks
5. At least one measurable lesion according to RECIST v1.1 criteria
6. Have adequate renal and hepatic function
7. Patients voluntarily joined the study and signed informed consent
Exclusion Criteria
2. Active central nervous system metastasis without surgery or radiotherapy
3. In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months
4. Presence with uncontrollable third space effusion
5. Have undergone other anti-tumor treatment within 4 weeks before the first dose
6. A history of immune deficiency
7. Clinically significant cardiovascular disorders
8. Known or suspected interstitial lung disease
9. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
10. Known hereditary or acquired bleeding tendency
11. Active hepatitis and liver cirrhosis
12. Presence of other serious physical or mental diseases or laboratory abnormalities
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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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 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-A1811-307
Identifier Type: -
Identifier Source: org_study_id
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