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HER2-Negative Breast CancerPhase 3NCT02225470

Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

A Phase 3 study testing E7389 (Eribulin Mesylate) and Vinorelbine injection in people with HER2-Negative Breast Cancer and Triple Negative Breast Cancer, run by Eisai Co., Ltd. at 35 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese population. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
E7389 (Eribulin Mesylate) and Vinorelbine injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
530 participants
Where
35 sitesChina
Study dates
26 Sep 2013to 22 Jun 2018
Phase
Phase 3
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

  • Subjects must meet all of the following criteria to be included in this study.
  • Female subjects with histologically or cytologically confirmed carcinoma of the breast:
  • Subjects with locally recurrent or metastatic disease who have received at least two, and a maximum of five, prior chemotherapeutic regimens for breast cancer, at least two of which were administered for treatment of locally recurrent or metastatic disease. Prior therapy must be documented by the following criteria prior to entry onto study:
  • Regimens must have included an anthracycline (e.g., doxorubicin, epirubicin), and a taxane (e.g., paclitaxel, docetaxel) in any combination or order. Prior treatment with any of these agents is not required if the agents are contraindicated for a prospective subject and documented in her medical history.
  • Some of these regimens may have been administered as adjuvant and/or neoadjuvant therapy, but at least two must have been given for locally recurrent or metastatic disease.
  • Subjects must have proven refractory to the most recent chemotherapy as documented by progression on or within 6 months of their last chemotherapy.
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  • Subjects with Her2/neu positive tumors may also have been treated with any Her2/neu targeted agents including antibodies, small compounds or investigational drugs.
  • Subjects may also have been treated with antihormonal therapy.
  • Have measurable disease meeting the following criteria:
  • At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node, or greater than or equal to 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.
  • Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based upon RECIST 1.1 to be used as a target lesion.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
  • Life expectancy of greater than or equal to 3 months.
  • subjects greater than or equal to 18 years old Age and less than or equal to 70 years old at the time of informed consent.
  • Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 mg/dL or calculated creatinine clearance greater than or equal to 40 mL/min per the Cockcroft and Gault formula.
  • Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL, and platelet count greater than or equal to 100 x 10^9/L.
  • Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN); and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3.0 times ULN (in the case of liver metastases less than or equal to 5.0 times ULN).
  • Subject willing and able to comply with the study protocol for the duration of the study.
  • All female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation greater than or equal to 1 menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy).
  • Female subjects of child-bearing potential must agree to use two forms of highly effective contraception from the last menstrual period prior to randomization (or use a double barrier method as described below until they are on two forms of highly effective contraception for at least one menstrual cycle), during study treatment, and for 3 months after the final dose of study treatment. Female subjects exempt from this requirement are subjects who practice total abstinence. If currently abstinent, the subject must agree to use a double barrier method of contraception, i.e. condom and occlusive cap (diaphragm or cervical/vault caps) with spermicide or until they are on two forms of highly effective contraception for at least one menstrual cycle if they become sexually active during study treatment and for 3 months after the final dose of study treatment. Highly effective contraception includes:
  • Placement of intrauterine device or system,
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault cap) with spermicide,
  • Established hormonal contraceptive methods: oral, injectable or implant. Female subjects who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product from the last menstrual period prior to randomization, and must continue to use the same hormonal contraceptive product during study treatment, and for 3 months after the final dose of study treatment,
  • Vasectomized partner with confirmed azoospermia.
  • Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol, with the understanding that the patient may withdraw consent at any time without prejudice.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from this study:
  • Subjects who have received any of the following treatments within the specified period before treatment start:
  • Vinorelbine has been administrated as neoadjuvant or adjuvant therapy within one year.
  • Chemotherapy, radiation, Her2/neu targeted agents including trastuzumab or hormonal therapy within three weeks.
  • Any investigational drug within four weeks.
  • Blood transfusion, blood preparations and hematopoietic factor preparations such as G-CSF within two weeks.
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  • Subjects of advanced breast cancer with vinorelbine effective therapy to CR/PR/SD, and PD occurred after vinorelbine discontinuing within 6 months.
  • Subjects with ineffective prior vinorelbine treatment.
  • Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
  • Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least four weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least four weeks before starting study treatment; and radiographic stability should be determined by comparing a contrast-enhanced CT or MRI brain scan performed during screening to a prior scan performed at least four weeks earlier.
  • Subjects with meningeal carcinomatosis.
  • Woman must not be pregnant as documented by a negative beta-human chorionic gonadotropin (beta-hCG) test with a minimum sensitivity 25 IU/L, or equivalent unit of beta-hCG, at Screening and Baseline; nor breastfeeding.
  • Severe/uncontrolled intercurrent illness/infection.
  • Significant cardiovascular impairment (history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).
  • Subjects with organ allografts requiring immunosuppression therapy.
  • Subjects with known positive HIV status.
  • Subjects who have had a prior malignancy, other than breast cancer, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated at least five years previously with no subsequent evidence of recurrence.
  • Subjects with preexisting neuropathy greater than Grade 2.
  • Subjects with a hypersensitivity to halichondrin B and/or a halichondrin B chemical derivative.
  • Subjects who participated in a prior eribulin clinical trial whether or not eribulin was received.
  • Known intolerance to eribulin or vinorelbine (or any of the excipients).
  • Any medical condition that in the investigator's opinion may preclude subject from being entered in the study.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • 01 Eisai Trial Site

    Beijing, Beijing Municipality

  • 03 Eisai Trial Site

    Beijing, Beijing Municipality

  • 33 Eisai Trial Site

    Beijing, Beijing Municipality

  • 35 Eisai Trial Site

    Beijing, Beijing Municipality

  • 04 Eisai Trial Site

    Bengbu, Anhui

  • 16 Eisai Trial Site

    Changchun, Jilin

  • 17 Eisai Trial Site

    Changchun, Jilin

  • 05 Eisai Trial Site

    Changsha, Hunan

  • 13 Eisai Trial Site

    Changsha, Hunan

  • 34 Eisai Trial Site

    Changsha, Hunan

  • 26 Eisai Trial Site

    Chengtu, Sichuan

  • 06 Eisai Trial Site

    Dalian, Liaoning

  • 07 Eisai Trial Site

    Fuzhou, Fujian

  • 08 Eisai Trial Site

    Fuzhou, Fujian

  • 20 Eisai Trial Site

    Guangzhou, Guangdong

  • 36 Eisai Trial Site

    Guangzhou, Guangdong

  • 40 Eisai Trial Site

    Hangzhou, Zhejiang

  • 11 Eisai Trial Site

    Harbin, Heilongjiang

  • 37 Eisai Trial Site

    Hefei, Anhui

  • 18 Eisai Trial Site

    Nanjing, Jiangsu

  • 31 Eisai Trial Site

    Nanjing, Jiangsu

  • 10 Eisai Trial Site

    Nanning, Guangxi

  • 22 Eisai Trial Site

    Qingdao, Shandong

  • 09 Eisai Trial Site

    Shanghai, Shanghai Municipality

  • 19 Eisai Trial Site

    Shenyang, Liaoning

  • 12 Eisai Trial Site

    Shijiazhuang, Hebei

  • 23 Eisai Trial Site

    Taiyuan, Shanxi

  • 27 Eisai Trial Site

    Tianjin, Tianjin Municipality

  • 14 Eisai Trial Site

    Wuhan, Hubei

  • 15 Eisai Trial Site

    Wuhan, Hubei

  • 24 Eisai Trial Site

    Xi'an, Shaanxi

  • 28 Eisai Trial Site

    Xi'an, Shaanxi

  • 21 Eisai Trial Site

    Yinchuang, Ningxia

  • 30 Eisai Trial Site

    Yunnan, Yunnan

  • 38 Eisai Trial Site

    Zhengzhou, Henan

Other trials in China

About this study

Official title: An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese population. Eligible female subjects will have measurable disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for assessment of disease.

Being tested
E7389 (Eribulin Mesylate), Vinorelbine injection
Keywords
Locally Recurrent or Metastatic Breast Cancer
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7389 (Eribulin Mesylate)Drug

  • Vinorelbine injectionDrug

Study groups in NCT02225470
Study groupRoleWhat they receive
Arm A, E7389 (Eribulin Mesylate)ExperimentalThe eribulin mesylate dose will be 1.4 mg/m2 administered as an intravenous bolus over 2 to 5 minutes on Days 1 and 8 of each 21-day cycle.
Receives: Drug: E7389 (Eribulin Mesylate)
Arm B, Vinorelbine injectionActive comparatorThe vinorelbine dose will be 25 mg/m2 administered as an intravenous bolus on Days 1, 8, and 15 of each 21-day treatment cycle.
Receives: Drug: Vinorelbine injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progression

    Measured: Baseline until date of recorded disease progression or death, or up to 2 years

  2. Progression-Free Survival (PFS) of Vinorelbine Arm by tumor assessment: Time to disease progression

    Measured: Baseline until date of recorded disease progression or death, or up to 2 years

  3. Maximum observed plasma concentration (Cmax) of Eribulin Arm in a minimum of 15 subjects

    Measured: Day 1 and Day 8

  4. Time at which the highest drug concentration occurs (tmax) of Eribulin Arm in a minimum of 15 subjects

    Measured: Day 1 and Day 8

  5. Area under the plasma concentration-time curve (AUC) of Eribulin Arm in a minimum of 15 subjects

    Measured: Day 1 and Day 8

  6. Terminal phase rate constant (lambda Z) of Eribulin Arm in a minimum of 15 subjects

    Measured: Day 1 and Day 8

  7. Terminal elimination phase half-life (t1/2) of Eribulin Arm in a minimum of 15 subjects

    Measured: Day 1 and Day 8

  8. Distribution volume at steady-state (Vss) of Eribulin Arm in a minimum of 15 subjects

    Measured: Day 1 and Day 8

  9. Total clearance (CL) of Eribulin Arm in a minimum of 15 subjects

    Measured: Day 1 and Day 8

Secondary outcomes (7)

  1. Overall Survival (OS)

    Measured: Baseline until date of death, or up 5 years

  2. Duration of Response

    Measured: Baseline until date of recorded disease progression or death or up to 5 years

  3. Objective Response Rate (ORR)

    Measured: Baseline until date of recorded disease progression or death, or up to 5 years

  4. Evaluate safety parameters such as electrocardiograms

    Measured: Baseline until date of recorded disease progression or death

  5. Evaluate safety assessments parameters such as vital signs( VS)

    Measured: Baseline until date of recorded disease progression or death

  6. Evaluate safety parameters such as adverse events (AEs)

    Measured: Baseline until date of recorded disease progression or death

  7. Evaluate safety parameters such as laboratory measurements

    Measured: Baseline until date of recorded disease progression or death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2014 (estimated)
  2. Study start26 Sep 2013
  3. Primary completion29 Sep 2017
  4. Study completion22 Jun 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02225470
Sponsor's protocol ID
E7389-C086-304
Status last verified
Dec 2017
First submitted
5 Aug 2014
Last updated
28 Aug 2018
Results posted
No

Publications

  • Yuan P, Hu X, Sun T, Li W, Zhang Q, Cui S, Cheng Y, Ouyang Q, Wang X, Chen Z, Hiraiwa M, Saito K, Funasaka S, Xu B. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. doi: 10.1016/j.ejca.2019.02.002. Epub 2019 Mar 29.

    PubMed 30928806

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E7389 (Eribulin Mesylate) and Vinorelbine injection in people with HER2-Negative Breast Cancer and Triple Negative Breast Cancer, run by Eisai Co., Ltd. at 35 sites 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 25 inclusion and 22 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progression (time frame: Baseline until date of recorded disease progression or death, or up to 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02225470, which also lists 1 linked publication.

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 28 Aug 2018.

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