Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
ConditionMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital
About this trial
This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.
Eligibility criteria
Qualifiers
Females and males ≥18 yrs old;
Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
Disqualifiers
Leptomeningeal involvement;
CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;
Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed 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;
Trial design
Treatments tested in this trial
- SHR-A1811
- Pyrotinib
- Bevacizumab
- Adebelizumab
Treatment groups
150 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov