advanced triple-negative breast cancer treated with anthracyclines and taxanes
Conditions
Interventions
treatment group:Toripalimab: 240 mg (> 40 kg) or 3 mg/kg (= 40 kg), ivgtt, first 60 minutes followed by 30 minutes if tolerated, d8, every 3 weeks
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18-70 ; 2. Histologically confirmed recurrent or metastatic breast cancer, including patients with stage IV inoperable initial treatment; 3. Histopathologically confirmed triple-negative breast cancer (HER-2 negative, ER<5% positive, PR<5% positive. HER-2 negative is defined as: HER-2 (0) or (1+) detected by immunohistochemistry ), HER-2 (2+) patients must undergo FISH testing and the result is negative, HER-2 (0) or (1+) patients can choose to undergo FISH testing and the result is negative. If there is metastasis pathology, The histology and pathology of metastases shall prevail; 4. Chemotherapy regimens containing anthracyclines and taxanes have been used in the past, and =2 lines of chemotherapy have been used in the advanced stage; first-line chemotherapy regimens do not include platinum drugs, and if platinum drugs have been used in the (neo) adjuvant treatment stage, the time between the last dose and recurrence should be more than 12 months; 5. For patients with recurrent or metastatic breast cancer who have not used immune checkpoint inhibitors for treatment, if PD-1 monoclonal antibodies have been used during (neo)adjuvant treatment, the time from the last dose to recurrence should be more than 12 months and there should be no recurrence during treatment. Grade 3 or higher IRAEs; 6. At least one measurable target lesion according to RECIST1.1 standards; 7. Asymptomatic or symptomatic patients with stable brain metastases after treatment (radiotherapy) and at least one evaluable target lesion in other locations besides brain metastases can be enrolled, but the time between the last radiotherapy and the last radiotherapy must be more than four weeks ; 8.ECOG score =2 points; 9. All patients must meet the following laboratory biochemical values before enrollment: ? Blood routine: hemoglobin (Hb) = 90g/L, white blood cell count (WBC) = 3.5×10^9/L, neutrophil count (ANC) = 1.5 ×10^9/L, platelet count (PLT) =75×10^9/L; ? Renal function: Serum creatinine = upper limit of normal value; ? Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase (ALP) = 2.5 ×ULN, total bilirubin =1.25×ULN; for patients with liver metastasis, AST, ALT, ALP =5 ULN, total bilirubin =1.5×ULN; 10. Expected survival time=12 weeks; 11. No history of serious heart, lung, liver, kidney and other important organ diseases, and no serious autoimmune diseases; 12. The patient understands the research procedures and signs the written informed consent form to express his agreement to participate in the research.
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 positive, pregnancy must be ruled out by ultrasound); 2. Women of childbearing age who are unwilling to take effective contraceptive measures during the research process; 3. Received axial bone radiotherapy within four weeks before the start of the study or the toxicity caused by previous radiotherapy has not recovered; 4. Participated in any investigational drug treatment within four weeks before the start of treatment; 5. Patients with symptomatic central system metastasis; 6. Accompanied by other active cancers, or a history of other malignant tumors within the past five years. The following conditions are excluded: ? Cured non-malignant melanoma skin cancer; ? Curable tumors: including cervical cancer in situ and superficial bladder cancer; ? Other solid tumors that have received radical treatment and have not recurred for 5 years or more transfer; 7. History of clinical symptoms of cardiovascular, liver, respiratory, renal and blood endocrine system or neuropsychiatric diseases; 8. Active infection occurs 2 weeks before enrollment and requires antibiotic treatment; 9. Untreated active hepatitis B; Note: Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV must be <1000 copies/ml (200IU/ml) before the first dose. Anti-HBV treatment should be received throughout the study chemotherapy period to avoid viral reactivation. For patients with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load(-), they do not need to receive preventive anti-HBV treatment, but they need to be closely monitored for viral reactivation; 10. Patients with active HCV infection (HCV antibody positive and HCV-RNA level higher than the detection limit) should receive live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Before the first dose is allowed Receive injectable inactivated virus vaccine against seasonal influenza within 30 days, but are not allowed to receive intranasal live attenuated influenza vaccine; 11. Diagnosed with immunodeficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 7 days before the first administration of the study; the use of physiological doses of glucocorticoids (=10 mg/day of prednisone or other effective drugs); 12. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1/2 antibody positive); 13. Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the trial results, prevent the subject from fully participating in the study, or other circumstances that the researcher deems unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Overall Survival, OS;CRs, PRs and SD=24 ;Safety;PROs; | — |
Countries
China
Contacts
Public ContactShi Yanxia
Sun Yat-sen University Cancer Center
Outcome results
None listed