Know Cancer

or
forgot password

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


N/A
18 Years
70 Years
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

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


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


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 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
- 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

level of IL-6 and IL-8

Outcome Time Frame:

2 days

Safety Issue:

No

Principal Investigator

Xichun Hu, MD.PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

Fudan BR2011-06

NCT ID:

NCT01543126

Start Date:

February 2011

Completion Date:

August 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms
  • Pleural Effusion

Name

Location