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IRCT2017100136491N1 IRCT 2017-11-19 Ministry of Research, Shiraz University of Medical Sciences, Pharmaceutical Sciences Research Center Studying the effect of addition of carboplatin and gemcitabine to standard therapy in improving response rate in breast cancer patients Evaluation of clinical and histopathological efficacy of carboplatin and gemcitabine as second line neoadjuvant therapy in locally advanced breast cancer patients 2017-11-22 anticipated 50 Complete https://irct.ir/trial/27260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Breast cancer. Intervention 1: Intervention group: Addition of second line neoadjuvant chemotherapy including Carboplatin intravenous injection with the dose of 5x target AUC and gemcitabine intravenous injection with the dose of 1 gram per square meter of body surface area, both for two to three cycles, to first line standard neoadjuvant chemotherapy. Intervention 2: Control group: Applying first line standard neoadjuvant chemotherapy including doxorubicin intravenous injection with the dose of 60 mg per square meter of body surface area along with cyclophosphamide intravenous injection with the dose of 600 mg per square meter of body surface area and paclitaxel intravenous injection with the dose of 175 mg per square meter of body surface area, all three applied for 4 cycles.
public ِDr. Laleh Mahmoudi
School of Pharmacy, Karafarin Street, 5th kilometer of Shiraz Isfahan highway
Shiraz Iran (Islamic Republic of) +98 71 3242 4127 mahmoudi_l@sums.ac.ir Pharmacotherapy Department, School of Pharmacy, Shiraz University of Medical Sciences scientific Dr. Laleh Mahmoudi
School of Pharmacy, Karafarin street, 5th kilometer of Shiraz Isfahan highway
Shiraz Iran (Islamic Republic of) +98 71 3242 4127 mahmoudi_l@sums.ac.ir Pharmacotherapy Department, School of Pharmacy, Shiraz University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 60 years Female C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group: Addition of second line neoadjuvant chemotherapy including Carboplatin intravenous injection with the dose of 5x target AUC and gemcitabine intravenous injection with the dose of 1 gram per square meter of body surface area, both for two to three cycles, to first line standard neoadjuvant chemotherapy. Control group: Applying first line standard neoadjuvant chemotherapy including doxorubicin intravenous injection with the dose of 60 mg per square meter of body surface area along with cyclophosphamide intravenous injection with the dose of 600 mg per square meter of body surface area and paclitaxel intravenous injection with the dose of 175 mg per square meter of body surface area, all three applied for 4 cycles. 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. 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). Ministry of Research, Shiraz University of Medical Sciences, Pharmaceutical Sciences Research Center Approved 2017-07-30 The Ethics Comittee of Vice Chancellery of Research Affairs, Shiraz University of Medical Sciences 7th floor, Shiraz University of Medical Sciences central building, Next to the red crecent, Zand St. Shiraz Iran (Islamic Republic of)