Studying the effect of addition of carboplatin and gemcitabine to standard therapy in improving response rate in breast cancer patients
Phase 2
Recruiting
- Conditions
- Breast cancer.Malignant neoplasm of breast
- Registration Number
- IRCT2017100136491N1
- Lead Sponsor
- Ministry of Research, Shiraz University of Medical Sciences, Pharmaceutical Sciences Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Female patients; Diagnosed with locally advanced breast cancer; 18 to 60 years of age. Exclusion criteria: Evidence of metastasis; Inflammatory breast cancer; Abnormal kidney function (Serum creatinine > 1.5 mg/dl); Abnormal liver function (Bilirubin and Serum transaminase > 2xULN); Abnormal Bone marrow function (Abnormal hemoglobin, WBC and platelet count)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete pathologic response. Timepoint: At the end of second line chemotherapy and surgery for the intervention group (approximately 4-6 months after start of therapy) and at the end of standard chemotherapy and surgery for the control group (approximately 4 months after start of therapy). Method of measurement: histopathologic evaluation of tumoral tissue of the breast.
- Secondary Outcome Measures
Name Time Method Renal adverse effects. Timepoint: Measured monthly for both groups and at the end of the second line chemotherapy in the intervention group (approximately 4-6 months after start of therapy) and at the end of the standard chemotherapy for the control group (approximately 4 months after start of therapy). Method of measurement: Serum creatinine measurment and calculation of glomerular filteration rate (GFR).;Bone marrow suppression. Timepoint: Measured monthly for both groups and at the end of the second line chemotherapy in the intervention group (approximately 4-6 months after start of therapy) and at the end of the standard chemotherapy for the control group (approximately 4 months after start of therapy). Method of measurement: complete blood count (white blood cells, hemoglobin, platelet).