NCT04002284

Anlotinib in Metastatic HER2 Negative Breast Cancer

The Efficacy and Safety of Anlotinib in Metastatic HER2 Negative Breast Cancer, a Single Arm Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Peng Yuan · Unknown
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis of this study is to discover if the anlotinib can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.

Detailed description

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.

Conditions

• Breast Neoplasm
• Antineoplastic Agents
• Anlotinib

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride	Anlotinib 12mg p.o. d1-14, 21days/cycle

Timeline

• Start date: 2018-07-12
• Primary completion: 2020-01-10
• Completion: 2020-03-15
• First posted: 2019-06-28
• Last updated: 2020-07-29

Locations

1 site across 1 country: China