<?xml version='1.0' encoding='UTF-8'?><xml><records><record><source-app name="HighWire" version="7.x">Drupal-HighWire</source-app><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Hu, Nanlin</style></author><author><style face="normal" font="default" size="100%">Si, Yiran</style></author><author><style face="normal" font="default" size="100%">Yue, Jian</style></author><author><style face="normal" font="default" size="100%">Sun, Tingting</style></author><author><style face="normal" font="default" size="100%">Wang, Xue</style></author><author><style face="normal" font="default" size="100%">Jia, Zhuqing</style></author><author><style face="normal" font="default" size="100%">Gao, Songlin</style></author><author><style face="normal" font="default" size="100%">Li, Qiao</style></author><author><style face="normal" font="default" size="100%">Shao, Yang</style></author><author><style face="normal" font="default" size="100%">Wang, Jiayu</style></author><author><style face="normal" font="default" size="100%">Luo, Yang</style></author><author><style face="normal" font="default" size="100%">Ma, Fei</style></author><author><style face="normal" font="default" size="100%">Xu, Binghe</style></author><author><style face="normal" font="default" size="100%">Yuan, Peng</style></author></authors><secondary-authors></secondary-authors></contributors><titles><title><style face="normal" font="default" size="100%">Anlotinib has good efficacy and low toxicity: a phase II study of anlotinib in pre-treated HER-2 negative metastatic breast cancer</style></title><secondary-title><style face="normal" font="default" size="100%">Cancer Biology and Medicine</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2021-08-01 00:00:00</style></date></pub-dates></dates><pages><style  face="normal" font="default" size="100%">849-859</style></pages><doi><style  face="normal" font="default" size="100%">10.20892/j.issn.2095-3941.2020.0463</style></doi><volume><style face="normal" font="default" size="100%">18</style></volume><issue><style face="normal" font="default" size="100%">3</style></issue><abstract><style  face="normal" font="default" size="100%">Objective: Anlotinib is a novel tyrosine kinase inhibitor blocking angiogenesis. This study was performed to assess the efficacy and safety of anlotinib in patients with metastatic breast cancer.Methods: Patients with HER2-negative breast cancer, who were pre-treated with anthracycline or taxanes in a neoadjuvant, adjuvant, or metastatic setting, and had treatment failure after at least one prior chemotherapy regimen in the metastatic setting were enrolled. Anlotinib was administered at 12 mg daily for 14 days in a 21-day cycle until disease progression or unacceptable toxicity occurred. Simultaneously, 5–10 mL of venous blood was collected to perform circulating tumor DNA (ctDNA) testing every 2 treatment cycles. The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival, safety, and biomarkers.Results: Twenty-six eligible patients were enrolled, with a median age of 56 (30–75) years. The median follow-up time was 10.5 months. The ORR was 15.4%, the DCR was 80.8%, and the median PFS was 5.22 months (95% confidence interval 2.86–6.24). Fourteen (53.8%) patients survived for more than 10 months. The changes in the detectable ctDNA variant allele frequency were consistent with the tumor response. The most common treatment-related adverse events were hypertension (57.7%), thyroid-stimulating hormone elevation (34.6%), and hand-foot syndrome (23.1%).Conclusion: Anlotinib showed objective efficacy with tolerable toxicity in heavily pre-treated, metastatic HER2-negative breast cancer. The dynamic changes in the ctDNA variant allele fraction may be predictive of the tumor response.</style></abstract></record></records></xml>