Advanced Triple-Negative Breast Cancer
Conditions
Interventions
Control group:The MDT formulates an anti-tumor treatment plan comprehensively based on clinical practice guidelines and the patients condition.
Study group:Based on the reference PTC-multi-omics AI prediction results, the treatment plan is formulated by the multidisciplinary team (MDT) after comprehensive
Sponsors
Arion Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Absence of disturbance of consciousness, fully understanding and voluntarily signing the informed consent form, and voluntarily participating in this study; 2.Age >= 18 years; 3.Histologically or cytologically confirmed breast cancer; 4.Patients with metastatic breast cancer assessed by the MDT team as not eligible for curative surgery and having received at least three lines of standard therapy; 5.At least one measurable lesion according to RECIST 1.1 criteria; 6.ECOG performance status 0–2; 7.Agreement to provide tissue specimens via surgery/biopsy (for PTC culture/omics sequencing); 8.Adequate bone marrow, liver, and kidney function, with laboratory tests within 7 days before the first dose meeting the following requirements (if values are at the, comprehensive clinical judgment shall apply): (1). Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelets >= 100 × 10^9/L, and hemoglobin >= 90 g/L (no blood transfusions, blood products, granulocyte colony-stimulating factor, or other hematopoietic stimulants within 7 days before laboratory tests); (2). Serum total bilirubin = 2+, 24-hour urine protein quantification should be = 12 weeks; 9.Female participants of childbearing potential must agree to use effective contraception during the trial.
Exclusion criteria
Exclusion criteria: 1. Toxicity related to prior anti-tumor therapy has not recovered to = 2;left ventricular ejection fraction (LVEF) 38.5°C) during screening or before the first dose; 11. Active pulmonary tuberculosis (TB) or receipt of anti-TB treatment within 1 year before the first dose; 12. Pregnancy (positive pregnancy test before dosing) or breastfeeding; 13.Any other reasons judged by the investigator that make the patient unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Duration of Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactPan Yong
Arion Cancer Center
Outcome results
None listed