Triple negative breast cancer. Breast, unspecified
Conditions
Interventions
Intervention 1: Arm A:Docetaxel 70 mg/m2 and Carboplatin 7 AUS every three weeks with granulocyte colony-stimulating factor for 6 course. Intervention 2: Arm B: Doxorubicin Hydrochloride 60 mg/m2 and
Treatment - Drugs
Arm A:Docetaxel 70 mg/m2 and Carboplatin 7 AUS every three weeks with granulocyte colony-stimulating factor for 6 course
Arm B: 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 AUS every three weeks with G-CSF for
Sponsors
Vice chancellor for research, Kermanshah University Of Medical Sciences and Health Services
Eligibility
Sex/Gender
Female
Age
21 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: The tumor must have been determined to be human epidermal growth factor receptor 2 (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; Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 90 days prior to randomization; Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS;History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization;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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival. Timepoint: 2- and 5-year. Method of measurement: Observation.;Progression-free Survival. Timepoint: 2- and 5-year. Method of measurement: Observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutropenia. Timepoint: every 21 days. Method of measurement: Experimental.;Grade 3-4 vomiting. Timepoint: every 21 days. Method of measurement: Experimental.;Grade 3-4 thrombocytopenia. Timepoint: every 21 days. Method of measurement: Experimental.;Peripheral neuropathy. Timepoint: every 21 days. Method of measurement: Experimental. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMasoud Sadeghi
Kermanshah University of Medical Sciences
Outcome results
None listed