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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01543126

Enrollment

Registered

2012-03-02

Start date

2011-02-28

Completion date

2013-02-28

Last updated

2013-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
level of IL-6 and IL-8	2 days

Countries

China

Outcome results