Study design and patients
leptomeningeal disease, extracranial lesion, TNBC, HER-2, Cancer
UNCONTROLLED HYPERTENSION, ADVANCED SOLID TUMOR, BRAIN METASTASES, ONCOLOGY, CANCER
In this phase II trial, pretreated patients with advanced (recurrent or metastatic) TNBC in Harbin Medical University Cancer Hospital were enrolled. ER and PR negative was defined as < 1% in the immunohistochemistry (IHC) nuclear staining. HER-2 negative was defined as IHC staining 0 or 1+, or IHC staining 2 + with fluorescence in situ hybridization or chromogenic in situ hybridization negative. Eligible patients must have received at least one chemotherapy regimen in the advanced setting; had at least one measurable extracranial lesion according to the Response Evaluation Criteria in Advanced Solid Tumors (RECIST) version 1.1; and had an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. Patients with active brain metastases, leptomeningeal disease or uncontrolled hypertension were excluded. Those who had previously taken antiangiogenic agents (except bevacizumab) or etoposide were also excluded.The study was approved by the Ethics Committee of the Harbin Medical University Cancer Hospital and was performed in accordance with the Declaration of Helsinki. All patients have signed the informed consent form before any procedure. The study was registered at chictr.org.cn (Number: ChiCTR1800018497) on 20/09/2018.