Triple negative breast cancer
Conditions
Interventions
Control Group :Regular Medication
Experimental group:Medication based on MiniPDX drug sensitivity test + transcriptome sequencing results + Medication based on MiniPDX drug sensitivity test results
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women between 18 and 70 years old; 2. ECOG score: 01 points; 3. Estimated survival period >=3 months; 4. Recurrence (unresectable) or metastatic triple-negative breast cancer confirmed by histopathology; The pathology of the primary lesion or metastasis in our hospital was clearly triple negative, namely ER, PR, and HER-2 negative. ER and PR negative are defined as: ER=90 g/L (no blood transfusion within 14 days); ANC >= 1.5x10^9/L; PLT >= 75x10^9/L; Liver function: total bilirubin TBIL<=1.5 ULN; ALT and AST<=3 ULN; Renal function: serum Cr <=1 ULN; 9. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
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 administration, if it is positive, pregnancy must be ruled out by ultrasound); 2. Women of childbearing age who are unwilling to take effective contraceptive measures during the research; 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. Have received any anti-PD-1 or anti-PDL-1, CTLA-4 monoclonal antibody therapy in the past, or any other antibodies or drugs that target T cell costimulation or checkpoint pathways as specific targets; 6. Patients with active or autoimmune diseases that have a history of disease and may relapse (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, Vasculitis, glomerulitis, etc.), or high-risk patients (such as receiving an organ transplant and requiring immunosuppressive treatment). Except for autoimmune hypothyroidism that requires only hormone replacement therapy or skin diseases that do not require systemic treatment; 7. Patients who need to receive systemic corticosteroids (dose equivalent to> 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before enrollment or during the study period. Use topical topical or inhaled corticosteroids, or short-term (<=7 days) use of corticosteroids for the prevention or treatment of non-autoimmune, except for infrequent allergic diseases; 8. Patients with symptomatic central system transfer. Those with stable asymptomatic brain metastases who have received radiotherapy and have at least one evaluable target lesion in other parts of the brain can be included in the group, but there must be an interval of more than four weeks from the last radiotherapy; 9. Have a history of other malignant tumors in the past five years, except for cured skin non-malignant melanoma and cervical carcinoma in situ; 10. Failure of important organs or other serious diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina pectoris, and pericardial effusion with obvious symptoms within 6 months before enrollment Fluid or unstable arrhythmia; 11. History of severe neurological or psychiatric diseases; severe infections; active disseminated intravascular coagulation or other concomitant diseases that, according to the judgment of the investigator, seriously endanger the safety of the patient or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression Free Survival;Clinical Safety;Biomarker Detection; | — |
Countries
China
Contacts
Public ContactHu Xichun
Fudan University Shanghai Cancer Center
Outcome results
None listed