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

NCT ID: NCT01543126

Last Updated: 2013-07-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-02-28

Brief Summary

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

Detailed 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

Conditions

Metastatic Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pleural effusion

patients with pleural effusion

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xichun Hu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xichun Hu, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, , China

Countries

China

Other Identifiers

Fudan BR2011-06

Identifier Type: -

Identifier Source: org_study_id