Advanced Triple-negative Breast Cancer (TNBC)
Conditions
Interventions
Treatment with Sintilimab combined with Bevacizumab plus standard second-line chemotherapy:N/A
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years old; 2.Advanced triple - negative breast cancer (TNBC) confirmed by histopathology, as defined by the latest ASCO/CAP guidelines. Based on the latest and previous pathological findings, the following criteria must be met simultaneously; 3.Progressive disease confirmed by imaging studies following the most recent prior treatment; 4.Availability of archived recent or fresh tumor tissue samples; 5.Have received first - line standard chemotherapy for unresectable locally advanced or metastatic disease; 6.Presence of measurable or evaluable lesions, as assessed per RECIST Version 1.1 (RECIST v1.1). 7.Expected survival time of >= 3 months; 8.ECOG performance status of 0 or 1; 9.Normal function of major organs (within 14 days prior to enrollment), meeting the following criteria: Neutrophils >= 1.5 × 10?/L; Platelet count >= 100 × 10?/L; Hemoglobin >= 90 g/L Serum creatinine = 50 mL/min Total serum bilirubin = 50% and 12-lead electrocardiogram: QTcF < 480 ms; 10.No current childbearing plan and agreement to use contraception during the trial period; 11.The patient under observation or their legal representative has been informed of the nature of the study, understands the provisions in the protocol, is able to ensure compliance, and has signed the informed consent form for experimental treatment.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or intolerance to any component or excipient of the study treatment; 2.Presence of central nervous system (CNS) metastases; 3.Spinal cord compression without prior surgery or radiotherapy; or a history of diagnosed and treated spinal cord compression without evidence of clinical stability for more than 2 weeks prior to administration. 4.A history of or current interstitial pneumonia/pulmonary disease or non-infectious pneumonia requiring systemic corticosteroid therapy; or suspected interstitial pneumonia/pulmonary disease or non-infectious pneumonia that cannot be ruled out by imaging examinations during the screening period. 5.Uncontrolled hypercalcemia, or hypercalcemia of clinical significance (symptomatic); 6.A history of other malignant tumors within 5 years prior to enrollment; 7.Receipt of systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 14 days prior to enrollment. 8.Patients with confirmed uncontrolled concurrent diseases or disorders (including significant mental illness or social conditions) that, in the investigator’s judgment, may affect compliance with study procedures. 9.Pregnant or lactating women; 10.Other circumstances that, in the investigator’s judgment, make the patient unsuitable for participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) assessed per RECIST v1.1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Duration of Response (DOR);Overall Survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactHongqiang Guo
Henan Cancer Hospital
Outcome results
None listed