Status:
RECRUITING
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
HER2-PositiveRecurrent or Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Eligibility Criteria
Inclusion
- Women aged 18 to 75 (inclusive)
- HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
- ECOG score is 0 or 1
- An expected survival of ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Have adequate renal and hepatic function
- Patients voluntarily joined the study and signed informed consent
Exclusion
- Have other malignancies within the past 5 years
- Active central nervous system metastasis without surgery or radiotherapy
- In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months
- Presence with uncontrollable third space effusion
- Have undergone other anti-tumor treatment within 4 weeks before the first dose
- A history of immune deficiency
- Clinically significant cardiovascular disorders
- Known or suspected interstitial lung disease
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
- Known hereditary or acquired bleeding tendency
- Active hepatitis and liver cirrhosis
- Presence of other serious physical or mental diseases or laboratory abnormalities
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2032
Estimated Enrollment :
864 Patients enrolled
Trial Details
Trial ID
NCT06057610
Start Date
October 16 2023
End Date
October 1 2032
Last Update
April 20 2025
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029