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

Metastatic Breast Cancer Clinical Trial

Official title:

A Prospective Study Assessing the Correlation Between Disease Prognosis and the Level of IL-6 and IL-8 Level in Blood and Pleural Effusion Before and After Chemotherapy in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01543126
• Other study ID #: Fudan BR2011-06
• Status: Terminated
• Phase: N/A
• First received: February 27, 2012
• Last updated: July 24, 2013
• Start date: February 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Pleural Effusion

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of IL-6 and IL-8		2 days	No