Breast NeoplasmsPhase 4ELEGANTNCT02549677
Epirubicin Versus Docetaxel Plus Cyclophosphamide in Lymph Node Negative, ER-positive, Her2-negative Breast Cancer
A Phase 4 study testing Epirubicin, Docetaxel and cyclophosphamide in people with Breast Neoplasms, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Epirubicin, Docetaxel and cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Epirubicin, Docetaxel, cyclophosphamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
Also called anthracycline
epirubicin, 90mg per square meter, every 3 weeks, day 1
DocetaxelDrug
Also called taxotere
docetaxel, 75mg per square meter, every 3 weeks, day 1
cyclophosphamideDrug
cyclophosphamide, 600mg per square meter, every 3 weeks, day 1
| Study group | Role | What they receive |
|---|---|---|
| EC regimen | Experimental | Epirubicin, cyclophosphamide Receives: Drug: Epirubicin; Drug: cyclophosphamide |
| TC regimen | Active comparator | docetaxel, cyclophosphamide Receives: Drug: Docetaxel; Drug: cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with grade 3-4 neutropenia assessed by CTCAE v4.0
number of participants with neutrophil count less than 1000 per milliliter
Measured: up to 16 weeks
Secondary outcomes (4)
number of participants with grade 3-4 leukopenia assessed by CTCAE v4.0
number of participants with leukocyte count less than 2000 per milliliter
Measured: 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℃
Measured: up to 16 weeks
breast cancer relapse
number of participants with any locoregional recurrence, contralateral breast cancer or distant metastasis
Measured: three years
all cause mortality
number of participans died from all cause
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhu, Ruijin Hospital
- Investigators
- Li Zhu, doctor, Principal investigator, Shanghai Jiao Tong University School of Medicine affiliated Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549677
- Sponsor's protocol ID
- RJBC1506
- Acronym
- ELEGANT
- Status last verified
- Oct 2022
- First submitted
- 6 Sep 2015
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02549677
- Acronym / sponsor ID
- ELEGANT / RJBC1506
- Conditions
- Breast Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC regimen | Experimental | Drug: Epirubicin, Drug: cyclophosphamideEpirubicin, cyclophosphamide |
| TC regimen | Active comparator | Drug: Docetaxel, Drug: cyclophosphamidedocetaxel, cyclophosphamide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpirubicinAlso: anthracyclineepirubicin, 90mg per square meter, every 3 weeks, day 1 | Drug | EC regimen |
| DocetaxelAlso: taxoteredocetaxel, 75mg per square meter, every 3 weeks, day 1 | Drug | TC regimen |
| cyclophosphamidecyclophosphamide, 600mg per square meter, every 3 weeks, day 1 | Drug | EC regimen, TC regimen |
Primary outcome
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
4 secondary outcomes
number of participants with grade 3-4 leukopenia assessed by CTCAE v4.0
Time frame: up to 16 weeks
number of participants with febrile neutropenia assessed by CTCAE v4.0
Time frame: up to 16 weeks
breast cancer relapse
Time frame: three years
all cause mortality
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhu, doctor principal investigator
Shanghai Jiao Tong University School of Medicine affiliated Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epirubicin, Docetaxel and cyclophosphamide in people with Breast Neoplasms, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with grade 3-4 neutropenia assessed by CTCAE v4.0 (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.