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

NCT02549677 | Completed Phase 4

• 1 other identifier: RJBC1506
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• number of participants with grade 3-4 leukopenia assessed by CTCAE v4.0

  up to 16 weeks

• number of participants with febrile neutropenia assessed by CTCAE v4.0

  up to 16 weeks

• breast cancer relapse

  three years

• all cause mortality

  three years

Study Arms (2)

EC regimen

EXPERIMENTAL

Epirubicin, cyclophosphamide

Drug: Epirubicin; Drug: cyclophosphamide

TC regimen

ACTIVE COMPARATOR

docetaxel, cyclophosphamide

Drug: Docetaxel; Drug: cyclophosphamide

Interventions

Epirubicin DRUG

epirubicin, 90mg per square meter, every 3 weeks, day 1

Also known as: anthracycline

EC regimen

Docetaxel DRUG

docetaxel, 75mg per square meter, every 3 weeks, day 1

Also known as: taxotere

TC regimen

cyclophosphamide DRUG

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

EC regimen; TC regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Epirubicin; Anthracyclines; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Li Zhu, doctor

  Shanghai Jiao Tong University School of Medicine affiliated Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 15, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)