Anlotinib in Metastatic HER2 Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04002284|
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Antineoplastic Agents Anlotinib||Drug: Anlotinib Hydrochloride||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Anlotinib in Metastatic HER2 Negative Breast Cancer, a Single Arm Phase II Clinical Trial|
|Actual Study Start Date :||July 12, 2018|
|Actual Primary Completion Date :||January 10, 2020|
|Actual Study Completion Date :||March 15, 2020|
anlotinib 12mg qd p.o. d1-14/21day/cycle
Drug: Anlotinib Hydrochloride
Anlotinib 12mg p.o. d1-14, 21days/cycle
Other Name: anlotinib
- objective response rate(ORR) [ Time Frame: through study completion, an average of 1 year ]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.
- disease control rate(DCR) [ Time Frame: through study completion, an average of 1 year ]Number of participants with stable disease or partial response or complete response treating by anloitnib according to RESIST criteria v1.1.
- Progression free survival (PFS) [ Time Frame: From date of enrollment until the date of first documented progression, assessed up to 24 months ]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.
- overall survival(OS) [ Time Frame: From date of enrollment until death, assessed up to 24 months ]OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
- Safety and Tolerability [ Time Frame: through study completion, an average of 1 year ]All the treatment-related adverse events occurred as assessed by CTCAE v4.0
- circulating tumor DNA biomarker [ Time Frame: From date of enrollment until the date of first documented progression, assessed up to 24 months ]biomarkers measurement in dynamic circulating tumor DNA sequencing on the day of enrollment and at the end of every two cycle (28 days one cycle)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002284
|National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College|
|Beijing, Beijing, China, 100021|
|Principal Investigator:||Peng Yuan||Chinese Academy of Medical Sciences|