Breast cancer
Conditions
Interventions
Single arm group:Sintilimab, trastuzumab, chemotherapy
Sponsors
He'nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with histologically confirmed advanced or metastatic breast cancer; 2.Patients who have progressed through two or more lines of chemotherapy, including patients with advanced or metastatic breast cancer who have progressed after trastuzumab treatment; 3.Aged 18 years to 75 years; 4.With a life expectancy of more than 3 months; 5.Have at least one measurable or evaluable lesion according to RECIST V1.1; 6.0-2 points according to ECOG PS Score; 7.Having full organ and bone marrow function, as defined below: (1)Blood routine examination: absolute neutrophil count >=1.5x10^9/L; Platelet count >=90x10^9/L; Hemoglobin content >= 9.0g /dL; (2)Liver function: serum total bilirubin (TBIL) = 50mL/min; The results of urine dipstick showed urinary protein <2+. (4)Coagulation function: activated partial thrombin time (APTT) and international standardized ratio (INR) <= 1.5xULN. 8.A 2-week washout period is required from front-line chemotherapy or targeted therapy.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, and would not take medically approved effective contraceptive measures throughout the trial period; 2.Patients who have previously used PD-1 antibody drugs and/or chemotherapy; 3.Allergic to sintilimab, trastuzumab and/or chemotherapy; 4.Patients with high risk of bleeding or perforation due to obvious tumor invasion of the aorta or trachea, or patients with fistula; 5.Have a past or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases; 6.Received live attenuated vaccine within 4 weeks prior to enrollment or planned during the study period; 7.Active, known or suspected autoimmune diseases; 8.Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 9.Untreated infected persons with acute or chronic active hepatitis B or C. Patients who are receiving antiviral therapy are monitored for virus copy number, and doctors will judge whether they are eligible for inclusion according to their individual situation. 10.Uncontrolled concurrent diseases include, but are not limited to: (1)HIV infected persons (HIV antibody positive); (2)Serious infections in the active stage or poorly controlled clinically; (3)Evidence of severe or uncontrollable systemic disease (e.g., severe psychiatric or neurological disease, epilepsy or dementia, unstable or non-compensatory respiratory, cardiovascular, liver or kidney disease, uncontrolled hypertension [i.e., hypertension greater than or equal to CTCAE Grade 2 hypertension after drug treatment]); (4)Patients with active bleeding or new thrombotic diseases are taking anticoagulant drugs or have bleeding tendency. 11.Patients with comorbidities that, according to the investigator's judgment, seriously endanger patient safety or affect the patient's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Disease remission time;Objective remission rate;Toxic and side effect;Living quality; | — |
Countries
China
Contacts
Public ContactPang Xiaohui
He'nan Provincial People's Hospital
Outcome results
None listed