Breast cancer. Malignant neoplasm of breast
Conditions
Interventions
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 wi
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
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 cyclophosphamid
Sponsors
Ministry of Research, Shiraz University of Medical Sciences, Pharmaceutical Sciences Research Center
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contact?Dr. Laleh Mahmoudi
Pharmacotherapy Department, School of Pharmacy, Shiraz University of Medical Sciences
Outcome results
None listed