2026-03-27
minor
Study Identification, Study Status, Oversight, Study Design, Arms and Interventions, Eligibility v4
Primary completion date2025-10-30→2028-12-30
Completion date2026-04-30→2029-06-30
Enrollment target125→150
Study arms5→6
InterventionsBevacizumab (Drug), Pyrotinib (Drug), SHR-A1811 (Drug)→Adebelizumab (Drug), Bevacizumab (Drug), Pyrotinib (Drug), SHR-A1811 (Drug)
Eligibility criteria+100 characters
Inclusion Criteria:
Females and males ≥18 yrs old;
Pathologically confirmed HER2-positive or HER2 [...] sed on previous bevacizumab therapy were excluded from Arm 3 and Arm 5 ,and Arm 6 excludes patients who have progressed on prior PD-1 or PD-L1 therapy;
No concurrent antitumor therapy for metastatic cancer othe [...]
Study titlerevised
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer withWith Brain Metastases
2024-10-07
minor
Study Identification, Study Status, Oversight, Study Design, Arms and Interventions v3
Enrollment target100→125
Study arms4→5
Study titlerevised
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer Withwith Brain Metastases
2023-10-17
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v2
Enrollment target75→100
Study arms3→4
Eligibility criteria+183 characters
Inclusion Criteria:
Females ≥18 yrs old;
Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
At least one measurable intracranial [...] o RANO-BM criteria, which had not received local treatment;
NoWithout prior cranial radiation and had no indication for immediate local treatment or refuse to local [...] ral surgery were admitted if no radiotherapy was performed.
Patients with HER2-Low disease must not have systemic treatment for brain metastases.
Prior HER2-target treatment, endocrine therapy and chemother [...] n previous bevacizumab therapy were excluded from Arm 3;
No otherconcurrent an [...] [...]
Study title+2 characters
Study of SHR-A1811 in HER2-positiveexpression Advanced Breast Cancer With Brain Metastases
2023-04-17
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04-30→confirmed 2023-03-31
Study sitesdetails revised at 1 of 1 site