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
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Zhengzhou University |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |