Breast CancerPhase 2NCT00965523
Study of E7389 for Advanced or Metastatic Breast Cancer
A Phase 2 study testing Eribulin Mesylate in people with Breast Cancer, run by Eisai Co., Ltd. at 5 sites in Japan.
Trial summary
The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously… Read more about this study
- Who is it for?
- Ages 20 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- 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
- 81 participants
- Where
- 5 sitesJapan
- Study dates
- Jan 2008to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with histologically or cytologically confirmed breast cancer.
- Patients who have received prior chemotherapy including anthracycline and taxane.
- Patients aged 20 - 74 years when giving informed consent and who have given written voluntary consent for participating in this study before the completion of Study 221.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
- Patients with a measurable lesion.
- Patients with an expected survival of ≥ 3 months from the start of study drug therapy.
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- Female patients in whom continued administration of E7389 following Study 221 will be useful.
- Patients who have met the criteria for starting the next cycle in Study 221.
- Namely, patients who meet all of the following criteria:
- Neutrophil count >= 1,500 /µL
- Platelet count >= 100,000 /µL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with hepatic metastasis)
- Total bilirubin <= 1.5 times ULN
- Serum creatinine <= 1.5 times ULN
- Non-hematological toxicity <= Grade 2 (excluding disease-associated events and laboratory abnormalities without clinical symptoms)
Who cannot join
- Patients with systemic infection with a fever (≥38.0°C).
- Patients with pleural effusion, ascites or pericardial fluid requiring drainage.
- Patients with brain metastasis presenting clinical symptoms.
- Pregnant women, nursing mothers, or premenopausal women of childbearing potential. Premenopausal women of childbearing potential are defined as women who are <12 months after the latest menstruation and are positive in pregnancy test performed for enrollment or who have not taken the test and do not consent to take an appropriate contraceptive measure. Post-menopausal women must be amenorrheic for at least 12 months to make sure that they have no potential for becoming pregnant.
- Patients with serious complications:
- Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension)
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- Patients with myocardial infarction within 6 months prior to study entry
- Patients with a complication of hepatic cirrhosis
- Patients with interstitial pneumonia and pulmonary fibrosis
- Patients with a bleeding tendency
- Patients with an active double cancer.
- Pregnant women or nursing mothers.
- Patients who have received extensive radiotherapy (≥30% of bone marrow).
- Patients who refuse to receive the supportive therapy of blood transfusion for myelosuppression.
- Patients who are participating in other clinical studies.
- Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Chūō, Tokyo
Study site
Fukuoka, Fukuoka
Study site
Kagoshima, Kagoshima-ken
Study site
Kure, Hiroshima
Study site
Nagoya, Aichi-ken
About this study
Official title: Phase II Extension Study of E7389 for Locally Advanced or Metastatic Breast Cancer
The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.
Read the detailed description
Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study 224. Objective response rate (ORR) and the number of subjects with adverse events are reported as outcome measures because these were the outcome measures of Study 221 which is a main study in the combined data. Also, safety analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.
- Conditions
- Breast Cancer
- Being tested
- Eribulin Mesylate
- Keywords
- Cancer, breast cancer, neoplasm, E7389, Eribulin
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin MesylateDrug
Eribulin mesylate 1.4 mg/m^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Eribulin Mesylate | Experimental | Not described Receives: Drug: Eribulin Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events.
Measured: Every week during treatment and up to 30 days after last dose of study treatment
Secondary outcomes (1)
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatsuo Watanabe, Study director, Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965523
- Sponsor's protocol ID
- E7389-J081-224
- Other IDs
- E7389-J081-221
- Status last verified
- Jul 2013
- First submitted
- 20 Aug 2009
- Last updated
- 15 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Extension Study of E7389 for Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00965523
- Acronym / sponsor ID
- E7389-J081-224
- Conditions
- Breast Cancer
- Keywords
- Cancer, breast cancer, neoplasm, E7389, Eribulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Posted 15 Aug 2013
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 (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.
Detailed description
Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study 224. Objective response rate (ORR) and the number of subjects with adverse events are reported as outcome measures because these were the outcome measures of Study 221 which is a main study in the combined data. Also, safety analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin Mesylate | Experimental | Drug: Eribulin Mesylate |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female patients with histologically or cytologically confirmed breast cancer.
- Patients who have received prior chemotherapy including anthracycline and taxane.
- Patients aged 20 - 74 years when giving informed consent and who have given written voluntary consent for participating in this study before the completion of Study 221.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
- Patients with a measurable lesion.
Key exclusion criteria (16 listed)
- Patients with systemic infection with a fever (≥38.0°C).
- Patients with pleural effusion, ascites or pericardial fluid requiring drainage.
- Patients with brain metastasis presenting clinical symptoms.
- Pregnant women, nursing mothers, or premenopausal women of childbearing potential. Premenopausal women of childbearing potential are defined as women who are <12 months after the latest menstruation and are positive in pregnancy test performed for enrollment or who have not taken the test and do not consent to take an appropriate contraceptive measure. Post-menopausal women must be amenorrheic for at least 12 months to make sure that they have no potential for becoming pregnant.
- Patients with serious complications:
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 MesylateEribulin mesylate 1.4 mg/m^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days. | Drug | Eribulin Mesylate |
Primary outcome
Number of Subjects With Adverse Events.
Time frame: Every week during treatment and up to 30 days after last dose of study treatment
1 secondary outcome
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Every 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tatsuo Watanabe study director
Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin Mesylate in people with Breast Cancer, run by Eisai Co., Ltd. at 5 sites in Japan.
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 15 inclusion and 16 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 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Subjects With Adverse Events. (time frame: Every week during treatment and up to 30 days after last dose of study treatment). 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 15 Aug 2013.