The purpose of this study is to compare the safety and efficacy of epirubicin plus cyclophosphamide versus docetaxel plus cyclophosphamide in lymph node negative, estrogen receptor (ER) positive, human epithelial growth factor receptor 2 (HER2) negative breast cancer patients as adjuvant chemotherapy.
This is a non-inferiority study. According to previous study results, the investigators hypothesize the incidence of grade 3-4 neutropenia is 40%, with a α of 0.05 and β of 0.8, a sample size of 264 cases if needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
epirubicin, 90mg per square meter, every 3 weeks, day 1
docetaxel, 75mg per square meter, every 3 weeks, day 1
cyclophosphamide, 600mg per square meter, every 3 weeks, day 1
Ruijin Hospital
Shanghai, Shanghai Municipality, China
number of participants with grade 3-4 neutropenia assessed by CTCAE v4.0
number of participants with neutrophil count less than 1000 per milliliter
Time frame: up to 16 weeks
number of participants with grade 3-4 leukopenia assessed by CTCAE v4.0
number of participants with leukocyte count less than 2000 per milliliter
Time frame: up to 16 weeks
number of participants with febrile neutropenia assessed by CTCAE v4.0
number of participants with neutropenia count less than 1000 per milliliter and temperature highe than 38.5℃
Time frame: up to 16 weeks
breast cancer relapse
number of participants with any locoregional recurrence, contralateral breast cancer or distant metastasis
Time frame: three years
all cause mortality
number of participans died from all cause
Time frame: three years
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