Breast NeoplasmsPhase 4NCT03583944
A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer
A Phase 4 study testing Eribulin Mesylate in people with Breast Neoplasms, run by Eisai Inc. at 18 sites in India.
Trial summary
The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Eribulin Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 18 sitesIndia
- Study dates
- 28 Mar 2018to 28 Jun 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with locally advanced or metastatic breast cancer.
- Participants must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless participants who are not suitable for these treatments.
- Participants must have documented disease progression within or on 6 months from their last anti-cancer therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
- Participants must have normal organ and marrow function as defined below:
- Absolute neutrophil count greater than (>) 1,500 per microliter (/mcL)
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- Hemoglobin >10.0 gram per deciliter (g/dL)
- Platelets >100,000/mcl
- Serum total bilirubin less than (<) 1.5*upper limit of normal (ULN)
- Serum aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase [SGPT]) <3*ULN or <5*ULN in the presence of liver metastases
- Serum creatinine <1.5 mg/dL.
- Females in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study.
Who cannot join
- Hypersensitivity to the active substance or any of the excipients.
- Participants who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.
- Participants receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition.
- Participants requiring concurrent anti-cancer therapy during the study period.
- Participants 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 4 weeks before starting study treatment.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
India18 sites
HEMATO-ONCOLOGY CLINIC Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, 380009
HealthCare Global Enterprises Ltd
Bangalore, Karnataka, 560027
Srinivasam Cancer Care Multispecialty Hospitals India Pvt Ltd
Bangalore, Karnataka, 560072
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
MNJ Institute of Oncology and Regional Cancer Centre
Hyderabad, Telangana, 500004
Sawai Man Singh Hospital
Jaipur, Rajasthan, 302001
J.K.Cancer Institute
Kanpur, Uttar Pradesh, 208002
Nilratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014
Netaji Subhash Chandra Bose Cancer Institute
Kolkata, West Bengal, 700016
IPGME&R S.S.K.M Hospital
Kolkata, West Bengal, 700020
King George's Medical University,(Erstwhile Chhatrapati Shahuji Maharaj Medical University)
Lucknow, Uttar Pradesh, 226003
Ajanta Research Centre, Ajanta Hospital & IVF Centre
Lucknow, Uttar Pradesh, 226005
Deep Hospital
Ludhiana, Punjab, 141002
Tata Memorial Hospital Department of Oncology
Mumbai, Maharashtra, 400012
KR Hospital Mysore Medical College
Mysore, Karnataka, 570001
HCG NCHRI Cancer Centre
Nagpur, Maharashtra, 440026
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Lokmanya Hospital
Pune, Maharashtra, 411033
About this study
Official title: Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.
- Conditions
- Breast Neoplasms
- Being tested
- Eribulin Mesylate
- Keywords
- E7389, Tumors, Breast, Breast Cancer, Breast Carcinoma, Neoplasms, Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin MesylateDrug
Also called Halaven
Eribulin mesylate IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Eribulin Mesylate 1.23 mg | Experimental | Participants will receive eribulin mesylate 1.23 mg intravenous (IV) infusion, given over 2 - 5 minutes on Days 1 and 8 of 21 days cycle for a total of 6 cycles. Receives: Drug: Eribulin Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Clinical Safety will be assessed by recording the adverse events (AEs) and serious AEs (SAEs) observed during the study period and its relation to the study medication. AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect.
Measured: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Number of Participants with TEAEs Related to Laboratory Parameters
AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.
Measured: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Secondary outcomes (2)
Objective Tumor Response
Radiological confirmation of objective response rate (ORR) will be assessed by the Response Evaluation Criteria in Solid Tumors(RECIST)criteria version 1.1. The response would be assessed based on the four response parameters -complete response(CR), partial response(PR), stable disease(SD), progressive disease(PD).CR is defined as disappearance of all target lesions. PR is seen when there is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameters. When there is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameters since the treatment started then, the response is evaluated as SD.PD is seen when there is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
Objective Response Rate (ORR)
ORR measures the response rate using the formula - CR+PR/ (number of eligible participants)*100. CR is defined as disappearance of all target lesions. PR is seen when there is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameters.
Measured: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start28 Mar 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
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 Eisai Inc.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583944
- Sponsor's protocol ID
- E7389-M065-401
- Status last verified
- Jul 2018
- First submitted
- 20 Jun 2018
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03583944
- Acronym / sponsor ID
- E7389-M065-401
- Conditions
- Breast Neoplasms
- Keywords
- E7389, Tumors, Breast, Breast Cancer, Breast Carcinoma, Neoplasms, Breast
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- 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 evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin Mesylate 1.23 mg | Experimental | Drug: Eribulin MesylateParticipants will receive eribulin mesylate 1.23 mg intravenous (IV) infusion, given over 2 - 5 minutes on Days 1 and 8 of 21 days cycle for a total of 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants with locally advanced or metastatic breast cancer.
- Participants must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless participants who are not suitable for these treatments.
- Participants must have documented disease progression within or on 6 months from their last anti-cancer therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
- Participants must have normal organ and marrow function as defined below:
Key exclusion criteria (6 listed)
- Hypersensitivity to the active substance or any of the excipients.
- Participants who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.
- Participants receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition.
- Participants requiring concurrent anti-cancer therapy during the study period.
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 |
|---|---|---|
| Eribulin MesylateAlso: HalavenEribulin mesylate IV infusion. | Drug | Eribulin Mesylate 1.23 mg |
Primary outcome
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Clinical Safety will be assessed by recording the adverse events (AEs) and serious AEs (SAEs) observed during the study period and its relation to the study medication. AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect.
Number of Participants with TEAEs Related to Laboratory Parameters
Time frame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.
2 secondary outcomes
Objective Tumor Response
Time frame: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
Objective Response Rate (ORR)
Time frame: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
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 Nov 2019.
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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.
Medical Director study director
Eisai Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eribulin Mesylate in people with Breast Neoplasms, run by Eisai Inc. at 18 sites in India.
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 12 inclusion and 6 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in India. 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 Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)). The study lists 2 primary outcomes in all. 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 Nov 2019.