advanced triple-negative breast cancer
Conditions
Interventions
treatment group: Cadonilimab: 10 mg/kg, ivgtt, first 60 minutes followed by 30 minutes if tolerated, d1, every 3 weeks
Gemcitabine: 1.4mg/m2, ivgtt, 30 minutes, day 1, 8, every 3 weeks
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate and sign informed consent. 2. The age of signing the informed consent is 18-75 years old, including female or male. 3. Patients with metastatic triple-negative breast cancer were confirmed by histopathology :HER-2 negative (according to the 2018 CAP/ASCO HER-2 testing guidelines), ER negative, and PR negative (IHC =1% and =6 months. 5. ECOG Physical condition score is 0 or 1. 6. Participants had at least one measurable lesion confirmed by CT or MRI according to the solid tumor response Evaluation Criteria (RECIST v1.1). Lesions that have previously received radiotherapy or other local treatment are generally not selected for measurement unless it is demonstrated that the lesion has progressed after radiotherapy or other local treatment. 7. The function of the major organs is normal, that is, it meets the relevant laboratory inspection standards: (1) Blood routine: neutrophil count >=1.5×10^9/L (no treatment with granulocyte colony piercing factor within 7 days prior to laboratory examination); Platelet count >=100×10^9/L (no platelet or platelet growth factor has been injected within 7 days prior to obtaining laboratory tests); Hemoglobin >=9g/dL (no blood transfusion or use of erythropoietin in the 7 days prior to obtaining a laboratory test). (2) Blood biochemistry :AST/ALT=30mL/min/1.73m^2 (according to Cockcroft-Gault formula). Total bilirubin =12 weeks. 10. No history of serious heart, lung, liver, kidney and other important organ diseases, no serious autoimmune diseases.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women (women of childbearing age must have a negative pregnancy test within 14 days before the first dose, if it is positive, the pregnancy must be ruled out by ultrasound); 2. Women of childbearing age who were unwilling to use effective contraception during the study; 3. Received axial bone radiotherapy within four weeks prior to study initiation or toxicity from prior radiotherapy did not recover; 4. Participated in any investigational drug therapy within four weeks prior to the start of treatment; 5. Patients with symptomatic central system metastasis; 6. With other active cancers, or a history of other malignancies within the past five years. Except for the following cases: ? cured non-malignant melanoma of the skin; ? Curative tumors: including cervical carcinoma in situ, superficial bladder cancer; (3) Other solid tumors that have received radical treatment and have not recurred or metastasized for 5 years or more; 7. History of cardiovascular, liver, respiratory, kidney, blood endocrine system or neuropsychiatric diseases with clinical symptoms; 8. Active infection occurred 2 weeks before enrollment, requiring antibiotic treatment; 9. Untreated active hepatitis B; Note: Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV viral load must be <1000 copies /ml (200IU/ml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study chemotherapy drug treatment. Subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV therapy, but need to closely monitor viral reactivation. 10. Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above detection limit) Received live vaccine within 30 days prior to first administration (cycle 1, day 1); Note: Injectable inactivated virus vaccine for seasonal influenza is allowed within 30 days prior to initial administration, but live attenuated influenza vaccine for intranasal use is not allowed; 11. Is diagnosed with an immune deficiency or is receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first administration of the study; The use of physiological doses of glucocorticoids (=10mg/ day of prednisone or equivalent) is permitted; 12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive); 13. Evidence of medical history or disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survial ;Objective Response Rate;Clinical Benefit Rate;Duration of Response;Safety;Patient-reported clinical outcomes; | — |
Countries
China
Contacts
Public ContactXin An
Sun Yat-sen University Cancer Center
Outcome results
None listed