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

NCT05186545 | Unknown Phase 2

• 1 other identifier: HMPL-012-SPRING-R101
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Breast Cancer; Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ORR

  up to 3 years

• DCR

  up to 3 years

• OS

  up to 3 years

• Adverse Events (AEs)

  up to 3 years

Study Arms (1)

Experimental

EXPERIMENTAL

surufatinib + fulvestrant + chidamide

Drug: surufatinib + fulvestrant + chidamide

Interventions

surufatinib + fulvestrant + chidamide DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the Informed Consent Form;
• 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);
• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (5)

Anyang Tumor Hospital

Anyang, China

RECRUITING

Henan University of Science and Technology First Affiliated Hospital

Luoyang, China

RECRUITING

Nanyang Second General Hospital

Nanyang, China

NOT YET RECRUITING

He'nan Cancer Hospital

Zhengzhou, China

RECRUITING

The Third People's Hospital of Zhengzhou

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

surufatinib; Fulvestrant; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Hong Zong, M.D.

CONTACT

+ 86 13523586882; 1157506518@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: July 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2025
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

CN (5)