locally advanced breast cancer. Malignant neoplasm of unspecified site of unspecified female breast
Conditions
Interventions
Intervention group: adding oxaliplatin with dose 130 mg per m2 for 4 cycles every 3 weeks to chemotherapy regimen.
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: Histologically confirmed locally advanced breast cancer Clinical stage T3, T4, and/or N2, N3 Patients with Eastern Cooperative Oncology Group performance status of 0 or 1 Absolute neutrophil count > 1500/ mm3 Hemoglobin > 8.0 g/dL Platelet count > 100,000/mm3 Creatinine < 2.5 times the upper limit of normal (ULN) Serum transaminases < 2.5 times ULN Serum alkaline phosphatase < 4 times ULN Total bilirubin < 2.5 times ULN
Exclusion criteria
Exclusion criteria: Active infection Pregnancy Other primary malignancy Any documented distant metastasis Uncontrolled systemic diseases (including severe cardiovascular, kidney and liver disease) Patients refusal to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of pathologic complete response. Timepoint: After surgery. Method of measurement: Histopathologic evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug toxicity including hematologic,hepatic renal toxicity. Timepoint: every 3 weeks during patients visit. Method of measurement: blood test for evaluation of hematologic; renal; hepatic factors. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMansoor Ansari
Shiraz University of Medical Sciences
Outcome results
None listed