Epirubicin Versus Docetaxel Plus Cyclophosphamide in Lymph Node Negative, ER-positive, Her2-negative Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison the Safety and Efficacy of Epirubicin Plus Cyclophosphamide (EC)Versus Docetaxel Plus Cyclophosphamide (TC) in Lymph Node Negative, ER Positive, Her2 Negative Breast Cancer Patients as Adjuvant Chemotherapy

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Epirubicin
* Drug: Docetaxel
* Drug: cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged ≥18 years and < 70 years with life expectancy > 12 months Have finished radical operation, pathologically verified no lymph node involvement Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be with ER positive, Her2 negative tumor. Adequate bone marrow function Adequate liver and renal function Has Eastern Cooperative Oncology Group (ECOG0 Performance Score 0-1; Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study; Written informed consent according to the local ethics committee requirements. Exclusion Criteria: Prior systemic or loco-regional treatment of breast cancer, including chemotherapy; Metastatic breast cancer; With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma; Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease; Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive; History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension; Has peripheral neuropathy ≥ grade 1; Patient is pregnant or breast feeding; Known severe hypersensitivity to any drugs in this study; Treatment with any investigational drugs within 30 days before the beginning of study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EC regimen<br>Epirubicin, cyclophosphamide | Drug: Epirubicin<br>* epirubicin, 90mg per square meter, every 3 weeks, day 1<br>* Other names: anthracycline;Drug: cyclophosphamide<br>* cyclophosphamide, 600mg per square meter, every 3 weeks, day 1<br>|
| Active Comparator: TC regimen<br>docetaxel, cyclophosphamide | Drug: Docetaxel<br>* docetaxel, 75mg per square meter, every 3 weeks, day 1<br>* Other names: taxotere;Drug: cyclophosphamide<br>* cyclophosphamide, 600mg per square meter, every 3 weeks, day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with grade 3-4 neutropenia assessed by CTCAE v4.0 | number of participants with neutrophil count less than 1000 per milliliter | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with grade 3-4 leukopenia assessed by CTCAE v4.0 | number of participants with leukocyte count less than 2000 per milliliter | 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℃ | up to 16 weeks | 
| breast cancer relapse | number of participants with any locoregional recurrence, contralateral breast cancer or distant metastasis | three years | 
| all cause mortality | number of participans died from all cause | three years |