breast cancer
Conditions
Interventions
The healthy controls:None
The benign controls:None
The breast cancer patients:None
Sponsors
Department of Oncology, the First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Healthy people: (1) Voluntarily sign the informed consent form; (2) Age 18~75 years old; (3) Healthy people undergoing physical examination without serious systemic diseases; 2. People with benign lesions: (1) Voluntarily sign the informed consent form; (2) Age 18~75 years old; (3) Pathological results confirm benign breast lesions; 3. People with breast cancer: (1) Voluntarily sign the informed consent form; (2) Aged 18~75 years old, female; (3) Patients with histologically confirmed incurable locally advanced or metastatic solid tumors, regardless of immunohistochemistry type; (4) If it is a metastatic patient, the subject must have measurable lesions detected by CT or MRI; (5) All unresectable locally advanced or metastatic solid tumors that have failed standard treatment, or have no standard treatment options, or are not suitable for standard treatment at this stage; (6) Neutrophil count (NEUT) >= 1.5 × 10^9/L, platelet count (PLT) >= 100 × 10^9/L; hemoglobin concentration >= 9.0 g/dL; (7) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) = 50 ml/min (calculated by Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration or Modification of Dietin Renal Disease formulas) (not necessary but 24-hour urine collection can be collected); (10) ECOG score = 3 months.
Exclusion criteria
Exclusion criteria: 1. Those with second primary tumors (except non-melanoma skin cancer in situ and cervical cancer in situ that have been cured and have not recurred within 3 years); 2. Severe or uncontrollable heart disease that requires treatment, congestive heart failure classified as grade 3 or 4 by the New York Heart Association (NYHA), unstable angina pectoris that cannot be controlled by medication, and symptoms within 6 months before selection History of myocardial infarction, severe arrhythmia requiring drug treatment (except atrial fibrillation or paroxysmal supraventricular tachycardia); 3. Daily activities require oxygen; 4. Grade >= 2 peripheral neuropathy; 5. Have had major surgery within the previous 4 weeks; 6.ECHO or MUGA scan shows LVEF = 160 mmHg and/or diastolic blood pressure >= 100 mmHg) or diabetes (glycated hemoglobin HbA1c >= 9.0%); 10. Pregnant or lactating women; 11. Baseline measurement, QTc interval > 480 ms; 12. Abdominal puncture is required to collect ascites >= once a week; 13. Symptomatic pleural effusion (less than 90% oxygen saturation); 14. Patients with (non-infectious) interstitial lung disease (ILD) or a history of pneumonia who require steroid treatment; severe lung function impairment caused by lung disease; 15. Newly diagnosed thromboembolic events requiring treatment within 6 months (patients with stable deep vein thrombosis of the lower extremities are allowed to be included); 16. There are other circumstances in which the researcher believes that the patient is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response evaluation criteria in solid tumors;Serum extracellular vesicles concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;Overall Survival;Mortality rate;Time to recurrence; | — |
Countries
China
Contacts
Public ContactXiaoxiang Guan
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed