CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 150 target
Drug / intervention
SHR-A1811 +3 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Age ≥18 years, female or male
  • ✓Pathologically confirmed HER2-positive or HER2-low advanced breast cancer
  • ✓At least one measurable intracranial lesion by RANO-BM criteria without prior local treatment
  • ✓No prior cranial radiation, no indication for immediate local treatment or refused local treatment
Key exclusion· 11
  • ✕Leptomeningeal involvement
  • ✕CNS complications requiring emergency neurosurgical intervention or uncontrolled symptomatic brain metastases
  • ✕Prior treatment with trastuzumab deruxtecan or any ADC with exatecan derivative topoisomerase 1 inhibitor
  • ✕Prior HER2 TKI progression excluded from Arm 2; prior bevacizumab progression excluded from Arm 3 & 5; prior PD-1/PD-L1 progression excluded from Arm 6

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05769010
NCT05769010Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting
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A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

Henan Cancer Hospital·interventional·Posted Mar 15, 2023·Updated Apr 1, 2026

In Brief

A Phase 2 clinical trial evaluating SHR-A1811, Pyrotinib, and 2 other interventions for Metastatic Breast Cancer. Currently recruiting, targeting 150 participants across 1 site.

Detailed Summary

This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202420252026202720282029
First PostedMar 15, 2023
Enrollment StartMar 31, 2023
Primary CompletionDec 30, 2028
Study CompletionJun 30, 2029
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 3.3 years agoPrimary completion in 2.5 years

Interventions

SHR-A1811drug

SHR-A1811: intravenous

Pyrotinibdrug

Pyrotinib: oral

Bevacizumabdrug

Bevacizumab: intravenous

Adebelizumabdrug

Adebelizumab: intravenous