Breast Neoplasm Clinical Trial
Official title:
The Efficacy and Safety of Anlotinib in Metastatic HER2 Negative Breast Cancer, a Single Arm Phase II Clinical Trial
The hypothesis of this study is to discover if the anlotinib can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.
Breast cancer is one of the most common malignant tumors in women, which is a serious threat
to women's health. Despite the continuous improvement of treatment, 30% of breast cancer
eventually develops into advanced breast cancer. The median survival of advanced breast
cancer after routine treatment is 2-3 years. The main treatments include chemotherapy,
endocrine therapy, and targeted therapy. The treatment of metastatic breast cancer (MBC) aims
to improve quality of life, reduce pain and prolong survival.
Angiogenesis plays an important role in tumor cell proliferation and metastasis. Various
anti-angiogenic drugs such as bevacizumab, sunitinib, sorafenib, etc. have been developed and
widely used in various tumors. Treatments such as colon cancer, lung cancer, and renal cell
carcinoma significantly improve PFS and OS in patients with advanced disease, and the adverse
reactions are well tolerated. However, anti-angiogenic therapy has certain limitations in the
treatment of advanced breast cancer.
Anrotinib hydrochloride capsule is a new drug independently developed in China. It is a
multi-target receptor tyrosine kinase inhibitor targeting angiogenesis-related kinases such
as VEGFR1/2/3, FGFR1/2/3 and other kinases such as cell growth-related kinases such as
PDGFRα/β, c-Kit, and Ret , and it was approved by China Food and Drug Administation for the
treatment of patients with locally advanced or metastatic non-small cell lung cancer who have
progressed or relapsed after receiving at least 2 systemic chemotherapy. Basic research shows
that anlotinib is effective in breast cancer cell lines, but lacks the results of clinical
application of advanced breast cancer. This study is based on the results of phase I clinical
trials of allerinib in a variety of advanced solid tumors, to explore its efficacy and safety
in HER2-negative advanced breast cancer.
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