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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05186545
Other study ID # HMPL-012-SPRING-R101
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2022
Est. completion date July 2025

Study information

Verified date August 2022
Source The First Affiliated Hospital of Zhengzhou University
Contact Hong Zong, M.D.
Phone + 86 13523586882
Email 1157506518@qq.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 63
Est. completion date July 2025
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Signed the Informed Consent Form; - 18-75 Years (concluding 18 and 75 Years), female; - Pathologically and cytologically confirmed non-resectable stage IV Her2 negative, HR positive (ER+ and / or PR+) breast cancer; - Relapsed or progressed after at least first-line endocrine therapy, with patients of primary endocrine resistance excluded (patients of recurrence and metastasis progressed more than 6 months after receiving endocrine therapy or more than 2 years after receiving adjuvant endocrine therapy are eligible; patients progressed more than 1 year but less than 2 years after adjuvant endocrine therapy are not eligible); - 2 weeks or more from the last endocrine therapy and 3 weeks or more from the last chemotherapy before enrollment; - At least one measurable lesion is required; - Life expectancy greater than 3 months; - ECOG(Eastern Cooperative Oncology Group): 0~1; - Sufficient organ and bone marrow functions as follows: Absolute Neutrophil Count (ANC) =1.5×10^9/L; Platelet Count of =100×10^9/L; Hemoglobin=90g/L; Total Bilirubin (TBIL)<1.5 x ULN; ALT and AST<1.5 x ULN; Serum Creatinine (SCr)<1.5×ULN; Endogenous creatinine clearance rate =50ml / min (Cockcroft Gault formula) Exclusion Criteria: - Previous treatment with VEGFR inhibitor, HDAC inhibitor or fulvestrant; - Organ surgery performed 6 weeks before enrollment; - A history of other malignancies within 5 years prior to enrollment, except for cervical carcinoma in situ, basal or squamous cell skin cancer; - Known hypersensitivity to any of the study drugs or excipients; - Hypertension that is not controlled by the drug, and is defined as: SBP =150 mmHg and/or DBP =90 mmHg; - International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN; - Poorly controlled diabetes before enrollment; - Clinically significant electrolyte abnormalities judged by researchers; - With any diseases or conditions that affected drug absorption, or the patient could not take drugs orally; - Patients with obvious evidence of bleeding tendency or medical history or hemoptysis within 3 months before enrollment, thromboembolism within 12 months; - Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%; - Active infection or serious infection that is not controlled by drug (=CTCAE v5.0 Grade 2); - History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies =1×10^4/ml); known hepatitis C virus infection with HCV RNA positive (copies =1×10^3/m); - Women who are pregnant or lactating; - Urinary protein = ++, and the 24-hour urine protein quantification is greater than 1.0g; - Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
surufatinib + fulvestrant + chidamide
surufatinib: 250 mg/d, QD PO; Fulvestrant: 500mg, im, Q4W; Chidamide 30mg, PO, BIW; Q4W

Locations

Country Name City State
China Anyang Tumor Hospital Anyang
China Henan University of Science and Technology First Affiliated Hospital Luoyang
China Nanyang Second General Hospital Nanyang
China He'nan Cancer Hospital Zhengzhou
China The Third People's Hospital of Zhengzhou Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary PFS PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. up to 3 years
Secondary ORR The proportion of patients with a confirmed complete response or partial response on two consecutive occasions=4 weeks apart. up to 3 years
Secondary DCR The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD). up to 3 years
Secondary OS The time from recruitment to death due to any cause. up to 3 years
Secondary Adverse Events (AEs) Adverse events (AEs) categorized by severity in accordance with the NCI CTC AE Version 5.0. up to 3 years
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