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An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:
An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer Refractory to Endocrine Therapy

Clinical Trial Summary

This is a prospective, single center, single arm phase II study designed to explore the efficacy and safety of surufatinib + fulvastrant + chidamide combinational treatment in HR positive breast cancer refractory to endocrine therapy.

Clinical Trial Description

This is a prospective, single center, single arm phase II study. In the safety lead-in stage, 6 subjects will be recruited and administered with surufatinib 250 mg/d, QD PO; Fulvestrant 500mg, im, Q4W; Chidamide 30mg, PO, BIW, with four weeks as a cycle. DLTs of the 6 subjects will be evaluated in the first cycle to determine the recommended dosage of combinational therapy. Then 57 subjects will be recruited and administered with the triplet regimen to explore the efficacy and safety of combinational treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05186545
Study type Interventional
Source The First Affiliated Hospital of Zhengzhou University
Contact Hong Zong, M.D.
Phone + 86 13523586882
Email 1157506518@qq.com
Status Recruiting
Phase Phase 2
Start date July 1, 2022
Completion date July 2025
View Details
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