Determination of efficacy and safety of Oxaliplatin in locally advanced breast cancer patients

Phase 2

Recruiting

• Conditions: locally advanced breast cancer.; Malignant neoplasm of unspecified site of unspecified female breast; C50.919

• Registration Number: IRCT20181224042104N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of pathologic complete response. Timepoint: After surgery. Method of measurement: Histopathologic evaluation.

Secondary Outcome Measures

Name	Time	Method
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.