(1) Objectives: Comparison of clinical, radiological and pathological response rates of neoadjuvant chemotherapy regimen containing doxorubicin and cyclophosphamide (AC) with paclitaxel and gemcitabine (PG) in locally advanced breast cancer.
1) Determination of clinical tumor and lymph nodes response to neoadjuvant chemotherapy with doxorubicin and cyclophosphamide based on comparison of the sizes of them before and after chemotherapy
2) Determination of clinical tumor and lymph nodes response to neoadjuvant chemotherapy with paclitaxel and gemcitabine based on comparison of the sizes of them before and after chemotherapy.
3) Determination of radiological tumor and lymph nodes response to neoadjuvant chemotherapy with doxorubicin and cyclophosphamide based on comparison of the sizes of them before and after chemotherapy by sonography.
4) Determination of radiological tumor and lymph nodes response to neoadjuvant chemotherapy with paclitaxel and gemcitabine based on comparison of the sizes of them before and after chemotherapy by sonography.
5) Determination of pathological tumor and lymph nodes response to neoadjuvant chemotherapy based on specimen of residual tumor after chemotherapy between 2 groups.
6) Determination of clinical tumor and lymph nodes response to neoadjuvant chemotherapy between 2 groups based on physical exam.
7) Determination of radiological tumor and lymph nodes response to neoadjuvant chemotherapy between 2 groups by sonography.
8) Prevalence of side effect (extremity edema, bone marrow suppression, alopecia) of neoadjuvant chemotherapy regimen.
(2) Design: Patients with locally advanced breast cancer were randomly assigned into 2 categories. Group 1 received AC (doxorubicin and cyclophosphamide) and the other group received GP (paclitaxel and gemcitabine). Primary tumor size by clinical and radiological evaluation were done and registered according different characteristics such as ulceration, peau d orange sign, having skin or chest wall fixation or not, palpable and matted axillary and supraclavicular lymph nodes. Patients received 4 cycles of chemotherapy regimen every 3 week and after receiving each chemotherapy cycle, changes of size and characteristics of clinical tumor is evaluated and each patients should performed cell blood count and liver function test, renal function test, sodium and potassium test. Finally before referring the patients for surgery, the size of tumor is evaluated clinically and by breast sonography one more time and also after surgery the size of tumor is evaluated in pathological specimen. According to RECIST criterion in pathology specimen after surgery, if there was disappearance of tumor, it means the response to the treatment was completed; and if 30% decrease in sum of longest diameters the response was partial. Progression was achieved when 20% increase in sum of longest diameter or appearance of new lesions. If no progression or partial response, stable disease was diagnosed.
(3) Setting and conduct: according to statistic study, 70 patients with breast cancer pathology at stages IIB or III based on AJCC10 randomized in 2 groups (each group with 35 patients) according to WWW.RANDOM.ORG.They were referred to radiation department of Namazi hospital in 2014 and participate in this trial.
(4) Participants including major eligibility 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.
(5) Intervention: according to randomized group, one group received doxorubicin 60 mg/m2 and Cyclophosphamide 600 mg/m2 on the first day and in the other arm Gemcitabine 1000 mg/m2, days 1 and 8, Paclitaxel 175 mg/m2 day 1 were used. Both regimens were repeated every 3 weeks.
(6) Main outcome measures (variables): physical exam before starting treatment and after each cycle of chemotherapy; Sonography before starting treatment and after completeness of chemotherapy; pathological response after chemotherapy.