Tumor cardiovascular
Conditions
Interventions
Control group:Placebo for injection (sterilized water for injection)
Experimental group:Recaticimab for Injection
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all of the following criteria: 1) Subjects must be fully informed and voluntarily sign a written informed consent form prior to any screening procedures. 2) Age between 18 and 80 years (inclusive), regardless of sex. 3) Histologically confirmed malignant breast tumor (Luminal B subtype or triple-negative subtype). 4) At least one measurable lesion confirmed by imaging according to RECIST version 1.1. 5) Eastern Cooperative Oncology Group (ECOG) performance status of 0–1. 6) Adequate organ function, defined as: a) Hematologic function: Absolute neutrophil count (ANC) >= 1.0×10^9/L; platelet count >= 70×10^9/L; hemoglobin >= 80 g/L. b) Cardiac function: Left ventricular ejection fraction (LVEF) >= 50%. c) Hepatic function: Total bilirubin = 50 mL/min (calculated using the Cockcroft–Gault formula). e) Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (APTT), or international normalized ratio (INR) (if receiving prophylactic anticoagulation) <= 1.5× ULN. 7) Expected survival time of more than 12 months.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in this trial: 1) Known severe hypersensitivity or allergy to the main components or excipients of the PCSK9 inhibitor, or a history of severe allergic constitution. 2) Failure to recover from previous anti-tumor therapy-related toxicities to <= Grade 1 or baseline level (except for alopecia and <= Grade 2 peripheral neuropathy). 3) Currently participating in another clinical study and receiving study treatment, or having received any other investigational drug within 3 months prior to the first administration of the study drug. 4) Pregnant or breastfeeding female patients. 5) Subjects deemed unsuitable for participation in this trial by the investigator for any other reason. 6) Subjects with incomplete data, poor compliance, inability to adhere to scheduled visits, likely to be lost to follow-up, or who withdraw from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological Complete Response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Cardiac function; | — |
Countries
China
Contacts
Public ContactBai Ming
The First Hospital of Lanzhou University
Outcome results
None listed