Effect of Pioglitazone in Breast Cancer
Phase 3
- Conditions
- Breast Cancer.Malignant neoplasm of breast
- Registration Number
- IRCT20180124038493N1
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 62
Inclusion Criteria
Women With Confirmed Pathologic Invasive Breast Cancer Represented by Mesaurable Visceral Metastases
These Women should Aged at least 18 years old
Performance Status(ECOG) should be 0-2
life Expectancy should be more than 3 months
Exclusion Criteria
Usage this group of drug during 12 months ago.
Class III/IV Heart failure of New YORK HEART ASSOCIATION
Hiv Positive, Pregnant or Breast Feading, Previous History or Active Bladder cancer
NCI TOXICITY CRITERIA Grade 3,4 (VER 2.0)
Total Billirubin more than 1.5 times upper limit Normal or liver enzymes more than 2.5 times upper limit Normal unless liver Metastasis make this limitation change to 5.
Osteoporetic Patients (who = Tscore -2.5SD)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment Radiologic Responses ( stable/partial/ complete/progressive). Timepoint: Before Intervention, Month 3, Month 6. Method of measurement: Recist criteria version 1.1.;Lesion Size. Timepoint: Before Intervention, Month 3, Month 6. Method of measurement: Ruler in ct scan software.
- Secondary Outcome Measures
Name Time Method Time to progression. Timepoint: Month 3 and 6 from start study. Method of measurement: Watching.;Survival. Timepoint: Month 3 and 6 from start study. Method of measurement: watching.;Response Rate (percentage of patients whose cancer shrinks or disappears after treatment). Timepoint: Month 3 and 6 from start study. Method of measurement: Radiographic Response.