A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or… (NCT06057610) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
China868 participantsStarted 2023-10-16
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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 criteria
✕. 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