Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02549677
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Li Zhu, Ruijin Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Epirubicin Drug: Docetaxel Drug: cyclophosphamide Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2015
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: EC regimen
Epirubicin, cyclophosphamide
Drug: Epirubicin
epirubicin, 90mg per square meter, every 3 weeks, day 1
Other Name: anthracycline

Drug: cyclophosphamide
cyclophosphamide, 600mg per square meter, every 3 weeks, day 1

Active Comparator: TC regimen
docetaxel, cyclophosphamide
Drug: Docetaxel
docetaxel, 75mg per square meter, every 3 weeks, day 1
Other Name: taxotere

Drug: cyclophosphamide
cyclophosphamide, 600mg per square meter, every 3 weeks, day 1




Primary Outcome Measures :
  1. number of participants with grade 3-4 neutropenia assessed by CTCAE v4.0 [ Time Frame: up to 16 weeks ]
    number of participants with neutrophil count less than 1000 per milliliter


Secondary Outcome Measures :
  1. number of participants with grade 3-4 leukopenia assessed by CTCAE v4.0 [ Time Frame: up to 16 weeks ]
    number of participants with leukocyte count less than 2000 per milliliter

  2. number of participants with febrile neutropenia assessed by CTCAE v4.0 [ Time Frame: up to 16 weeks ]
    number of participants with neutropenia count less than 1000 per milliliter and temperature highe than 38.5℃

  3. breast cancer relapse [ Time Frame: three years ]
    number of participants with any locoregional recurrence, contralateral breast cancer or distant metastasis

  4. all cause mortality [ Time Frame: three years ]
    number of participans died from all cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549677


Locations
Layout table for location information
China, Shanghai
Ruijin Hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
Layout table for investigator information
Principal Investigator: Li Zhu, doctor Shanghai Jiao Tong University School of Medicine affiliated Ruijin Hospital
Layout table for additonal information
Responsible Party: Li Zhu, doctor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02549677    
Other Study ID Numbers: RJBC1506
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors