Clinical trial of Phase ΙΙΙ of study of the efficacy of docetaxel and carboplatin with or without doxorubicin hydrochloride and cyclophosphamide in treating Iranian women with triple negative breast cancer: A adjuvant therapy study

Objectives: The aim of this trial is to evaluate OS, PFS and toxicity of Arm A compared to Arm B after adjuvant therapy in untreated triple negative breast cancer patients with Iranian ethnicity. Setting : A randomized and clinical trial in University Hospital Design: The patients randomizely are divided to two groups: 60 patients in Arm A (treated with Docetaxel 70 mg/m2 and Carboplatin 7 AUC every three weeks with granulocyte colony-stimulating factor (G-CSF) for 6 course) and 59 patients in Arm B(treated with Doxorubicin Hydrochloride 60 mg/m2 and Cyclophosphamide 600mg/m2 every three weeks with G-CSF for 4 course followed by Docetaxel 70 mg/m2 and Carboplatin 7 AUC every three weeks with G-CSF for 4 course)), between Jul 2011 and Aug 2016. 2-and 5-year overall survival and progression-free survival and also adverse affects for every group are calculated. Participants including major eligibility criteria: Inclusion criteria: The tumor must have been determined to be human epidermal growth factor receptor (HER2)-negative;The tumor must have been determined to be hormonal receptor-negative (ER-and PR-negative) Exclusion criteria:T4 tumors including inflammatory breast cancer; Radiologic evidence of metastatic disease;Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; History of non-breast malignancies; Active or History of cardiac disease; Patients known to be human immunodeficiency virus (HIV) positive; Active hepatitis B or hepatitis C with abnormal liver function tests;History of hospitalization in past 12 months for diabetes; Pregnancy or lactation at the time of study entry. Main outcome: Neutropenia,Vomiting,sepsis etc

Kermanshah University of Medical Sciences