Combination treatment for HR positive metastatic breast cancer

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

This study is testing a new combination treatment for women with hard-to-treat HR positive metastatic breast cancer to see if it is safe and effective after other therapies haven't worked.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Drugs / interventions: chemotherapy, surufatinib
• Locations: 5 sites (Anyang and 4 other locations)
• Trial ID: NCT05186545 on ClinicalTrials.gov

What this trial studies

This phase II study aims to evaluate the safety and efficacy of a combination treatment involving surufatinib, fulvestrant, and chidamide in women with HR positive, unresectable metastatic breast cancer that has not responded to prior endocrine therapy. Initially, a safety lead-in stage will recruit 6 participants to assess dosage and determine any dose-limiting toxicities. Following this, an additional 57 subjects will be treated with the combination regimen to further explore its effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-75 with non-resectable stage IV HR positive breast cancer that has progressed after at least one line of endocrine therapy.

Not a fit: Patients with primary endocrine resistance or those who have not progressed after prior endocrine therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HR positive metastatic breast cancer who have exhausted standard endocrine therapies.

How similar studies have performed: While this approach is exploratory, similar combination therapies have shown promise in treating resistant breast cancer, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Anyang and 4 other locations

• 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)

Study contacts

• Study coordinator: Hong Zong, M.D.

Conditions Breast Cancer; Breast Cancer Female