Patient Inclusion Criteria
bone lesions, peripheral nerve injury, allergy, Tumors, systemic infection, HER2-negative mBC, Cancer
BONE LESIONS, DISEASE, BRAIN METASTASES, ALLERGY, TUMORS, CONGESTIVE HEART FAILURE, ONCOLOGY, SYSTEMIC INFECTION, CANCER
This was a single-center, open-label, prospective phase II randomized control trial that enrolled female patients aged ≥18 years who were histologically diagnosed with HER2-negative mBC at the Beijing Cancer Hospital and received no more than 2 prior lines of chemotherapy. Patients had to have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or lytic or mixed bone lesions in the absence of measurable disease, as well as an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate organ and bone marrow function. Patients with uncontrolled brain metastases, congestive heart failure (NYHA class ≥II), previous peripheral nerve injury (≥grade II), allergy to study drugs or severe systemic infection were excluded.The study protocol and patient materials were approved by the independent Ethics Committee of Peking University Cancer Hospital & Institute (Approval No. 2018YJZ52). All participants provided informed consent before enrollment. This study was registered with clinicaltrials.gov (Identifier, NCT04192331).