IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer

Fudan University

Status: Terminated

Conditions: Metastatic Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01543126

Fudan BR2011-06

Details and patient eligibility

About

Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease

Full description

To assess the correlation between the disease prognosis and the level of IL-6 and IL-8 in blood and pleural effusion before and after chemotherapy in patients with metastatic breast cancer

Enrollment: 9 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female between 18 and 70 years old;
• Patients with histologic proved metastatic breast cancer;
• Pleural effusion with the volume of more than 1000ml, as documented by CT, X ray or ultrasound;
• There are no other diseases which cause the elevation of IL-6 or IL-8, such as cirrhosis of liver, anaphylactoid purpura, acute pancreatitis;
• With at least one measurable disease according to RECIST criteria,
• Normal laboratory results:ANC≥2.0×109/L,Hb≥80g/L,plt≥100×109/L,TB<UNL (<1.5 x UNL in patients with liver mets),ALT/AST< 1.5 x UNL (<2.5x UNL in patients with liver mets),AKP<5 x UNL(except bone mets),Cr<UNL;
• Normal functions with heart, liver,renal and bone marrow;
• Got ICF before enrollment;
• Life expectancy more than 12 weeks.

Exclusion criteria

• Pregnant or breast-feeding women or positive serum pregnancy test;
• Uncontrolled brain metastases;
• No recovery from previous radiation or accepted radiation within 4 weeks before enrollment;
• Participation in any investigational drug study within 4 weeks preceding treatment start;
• Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin;
• Serious uncontrolled intercurrent infections;
• Poor compliance.

Trial design

9 participants in 1 patient group

pleural effusion

Description:

patients with pleural effusion