Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
In phase Ib, our study is aimed to evaluate the safety and tolerance of SHR-A1811 combined with pyrotinib in breast cancer with brain metastasis, and confirm the recommended phase 2 dose combined with preliminary results of efficacy.
In phase II, our study is aimed to evaluate the efficacy and safety of SHR-A1811 combined with pyrotinib and bevacizumab at RP2D in breast cancer with brain metastasis.
Eligibility criteria
Qualifiers
More than 18 years old;
ECOG PS Score: 0~2;
Patients must have a life expectancy ≥ 3 months;
Brian metastasis confirmed by MRI, at least one measurable brain lesion based on RANO-BM with no prior radiotherapy;
Disqualifiers
Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture;
Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage;
Has CNS complications with the need for emergency intervention, or brain metastasis with poorly controlled symptoms by hormone or dehydration therapy, such as uncontrollable intracranial hypertension, mental disorder or epilepsy;
No disease progression during prior bevacizumab or EGFR-TKI;
Trial design
Treatments tested in this trial
- SHR-A1811
- Bevacizumab
- Pyrotinib
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov