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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Epirubicin; Drug: cyclophosphamide; Drug: Docetaxel

Detailed Description

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
• Enrollment (Actual): 294
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged ≥18 years and < 70 years with life expectancy > 12 months
2. Have finished radical operation, pathologically verified no lymph node involvement
3. Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be with ER positive, Her2 negative tumor.
4. Adequate bone marrow function
5. Adequate liver and renal function
6. Has Eastern Cooperative Oncology Group (ECOG0 Performance Score 0-1;
7. 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;
8. Written informed consent according to the local ethics committee requirements.

Exclusion Criteria:

1. Prior systemic or loco-regional treatment of breast cancer, including chemotherapy;
2. Metastatic breast cancer;
3. With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
4. 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;
5. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
6. History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension;
7. Has peripheral neuropathy ≥ grade 1;
8. Patient is pregnant or breast feeding;
9. Known severe hypersensitivity to any drugs in this study;
10. Treatment with any investigational drugs within 30 days before the beginning of study treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Li Zhu, doctor, Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: September 6, 2015
• First Submitted That Met QC Criteria: September 13, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cyclophosphamide; Epirubicin
• Other Study ID Numbers: RJBC1506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD