Breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: For intervention group: from antimetabolite group
gemcitabine 1000 mg/m2 in days 1 and 8 via intravenous injection in 30 minutes and paclitaxel 175 mg/m2 from taxan group in day one via intravenous in 3 hours every 3 weeks for 4 cycle as neoadjuvan
doxorubicin 60 mg/m2 in days 1 via intravenous injection in several minutes and cyclophosphamide 600 mg/m2 from alkylene group in day one via intravenous in several minutes every 3 weeks for 4 cycle
Treatment - Drugs
For control group: from antracyclins group
For intervention group: from antimetabolite group
Sponsors
Vice chancellor for research, Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: A) Inclusion criteria: positive pathology of breast cancer; Karnofsky performance status at least: 70; locally advanced breast cancer; age< 65 Years old; normal cardiac and liver and bone marrow function; normal and acceptable cardiac evaluation in high risk patients or past medical history of cardiac problem; filling the informed consent by patient. B) Exclusion criteria: receiving previous chemotherapy for breast cancer; clinical or pathological positive evidence of metastasis; underling disease which can’t receive chemotherapy; known contraindication for chemotherapy agent (taxan reaction); sever cardiac problem history such as heart failure, chest pain which needs medication, sever cardiac valve disease, myocardial infarction, uncontrolled blood pressure (systolic pressure above 180 mm/Hg and diastolic pressure above 100 mm/Hg); refusing treatment by patient.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response. Timepoint: Befor treatment start and every 3 weeks for 4 cycle after treatment. Method of measurement: Caliper measurment (milimeter).;Radiologic response. Timepoint: Befor treatment and 3month after chemotherapy. Method of measurement: Sonography.;Pathologic response. Timepoint: 3 months later after chemotherapy followed by surgery. Method of measurement: Pathologic size (milimeter). | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone marrow suppression. Timepoint: Befor chemotherpy and every 3 weeks after chemotherapy. Method of measurement: Lab data.;Extrimity edema. Timepoint: Befor chemotherpy and every 3 weeks after chemotherapy. Method of measurement: History and physical exam.;Alopecia. Timepoint: Befor chemotherpy and every 3 weeks after chemotherapy. Method of measurement: History and exam. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactLeila Moaddab Shoar
Shiraz University of Medical Sciences
Outcome results
None listed