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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Anlotinib 12mg p.o. d1-14, 21days/cycle
National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
objective response rate(ORR)
Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
Time frame: through study completion, an average of 1 year
disease control rate(DCR)
Number of participants with stable disease or partial response or complete response treating by anloitnib according to RESIST criteria v1.1.
Time frame: through study completion, an average of 1 year
Progression free survival (PFS)
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Time frame: From date of enrollment until the date of first documented progression, assessed up to 24 months
overall survival(OS)
OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Time frame: From date of enrollment until death, assessed up to 24 months
Safety and Tolerability
All the treatment-related adverse events occurred as assessed by CTCAE v4.0
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Time frame: through study completion, an average of 1 year