Breast cancer
Conditions
Interventions
Intervention Group:PCSK9 inhibitor 600mg Q3W ih
Control Group:Placebo 600mg Q3W ih
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) At the time of signing the ICF, the subject must be at least 18 years old; (2) Female; (3) Advanced breast cancer confirmed by histological examination by the Department of Pathology of the First Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Cancer Hospital and the First Hospital of Lanzhou University; (4) Previously treated according to the first-line standard treatment protocol (including the updated guidelines); (5) According to the RECIST v1.1 standard, there must be at least one measurable lesion; (6) ECOG PS is 0 or 1, and there was no deterioration within 2 weeks before the baseline and before randomization; (7) Progressed after standard first-line treatment (the treatment options for molecular subtypes are detailed in the standard 4); (8) LDL-C is >= 3.0 mmol/L or the tumor tissue is positive for PCSK9 staining.
Exclusion criteria
Exclusion criteria: (1) Based on the judgment of the researchers, any condition that the researchers consider detrimental to the participants' participation in the study or that may affect their compliance with the protocol regarding disease evidence (such as severe or uncontrolled systemic diseases, including active infections, severe chronic gastrointestinal diseases related to diarrhea, active bleeding disorders, major heart or psychological diseases/societal conditions, chronic diverticulitis or previous complex diverticulitis, history of allogeneic organ transplantation and/or substance abuse) is excluded; (2) Patients with a history of other primary malignant tumors, patients who have been cured of basal cell or squamous cell skin cancer or cervical carcinoma in situ are excluded; (3) Within 7 days before the grouping, the bone marrow reserve function and organ function were poor; 1) Hemoglobin 1.5 × ULN or when Gilbert syndrome (non-bound hyperbilirubinemia) is confirmed 1.5 × ULN; . 6) Any known liver diseases, including known hepatitis B carriers, hepatitis C, autoimmune liver diseases, and sclerosing cholangitis; 7) Currently suffering from severe, uncontrolled infections, or known to be infected with HIV; 8) Positive syphilis antibody test; 9) Active tuberculosis infection (clinical evaluation may include clinical history, physical examination, and imaging results, or tuberculosis tests in accordance with local practice); 10) Calculated CrCL by Cockcroft Gault formula is less than 50 mL/min (using actual weight); Female: CrCL (mL/min) = ( (140 - Age) × Weight (kg) × (0.85) ) / (Serum creatinine (mg/dL) × 72) Male: CrCL (mL/min) = ( (140 - Age) × Weight (kg) ) / (Serum creatinine (mg/dL) × 72) 11) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) > 1.5 × ULN; (4) The contraceptive measures taken do not comply with the local regulations regarding the contraceptive measures that can be taken by clinical research subjects; (5) Having uncontrolled or significant heart diseases, including: 1) Myocardial infarction or uncontrolled/unstable angina pectoris within 6 months before randomization; 2) Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg); 3) History of NCI CTCAE (version 4.0) >= 3 grade asymptomatic congestive heart failure (CHF) or NYHA standard >= II grade; 4) Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) < 50%; 5) Poor control of angina pectoris, severe arrhythmia that cannot be controlled by appropriate drugs, severe conduction abnormalities, or clinically obvious valvular disease. (6) Participating in another interventional treatment study or trial using medical devices within 4 weeks before randomization; (7) Brain metastasis; (8) Previous (within 90 days before randomization) treatment with PCSK9 monoclonal antibody (mAb); (9) Hypocholesterolemia, hypolipidemia and family history of PCSK9 inhibitors, hypersensitivity reaction to the study drug or its ex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactWu Yue
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed