Breast CancerPhase 1NCT01432886
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
A Phase 1 study testing E7389 in people with Breast Cancer, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose. 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?
- E7389
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesJapan
- Study dates
- Oct 2011to Dec 2013
- Phase
- Phase 1
- 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
- Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.
- Histologically or cytologically confirmed with breast cancer
- Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method
- Subjects who meet any of the following criteria:
- Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane
- Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane
Show all 10Show fewer
- Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1
- Subjects who have submitted written informed consent for study entry
Who cannot join
- Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment
- Subjects with severe active infection requiring active treatment
- Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
- Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives
- Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.
- Subjects who are pregnant (positive B-hCG test) or breastfeeding
- Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1 Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.
- Conditions
- Breast Cancer
- Being tested
- E7389
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7389Drug
Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E7389 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicity (DLT)
For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.
Measured: Up to 3 weeks
Number of Participants With Adverse Events
The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.
Measured: From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionDec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tadashi Nakanishi, Study director, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432886
- Sponsor's protocol ID
- E7389-J081-107
- Status last verified
- Aug 2016
- First submitted
- 12 Sep 2011
- Last updated
- 7 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Mukai H, Saeki T, Shimada K, Naito Y, Matsubara N, Nakanishi T, Obaishi H, Namiki M, Sasaki Y. Phase 1 combination study of eribulin mesylate with trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 positive breast cancer. Invest New Drugs. 2015 Feb;33(1):119-27. doi: 10.1007/s10637-014-0161-y. Epub 2014 Sep 23.
PubMed 25242374
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
- ClinicalTrials.gov ID
- NCT01432886
- Acronym / sponsor ID
- E7389-J081-107
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Posted 30 Mar 2015
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 the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E7389 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.
- Histologically or cytologically confirmed with breast cancer
- Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method
- Subjects who meet any of the following criteria:
- Adequate organ function
Key exclusion criteria (7 listed)
- Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment
- Subjects with severe active infection requiring active treatment
- Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
- Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives
- Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.
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 |
|---|---|---|
| E7389Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly. | Drug | 1 |
Primary outcome
Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Up to 3 weeks
For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.
Number of Participants With Adverse Events
Time frame: From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25242374Mukai H, Saeki T, Shimada K, Naito Y, Matsubara N, Nakanishi T, Obaishi H, Namiki M, Sasaki Y. Phase 1 combination study of eribulin mesylate with trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 positive breast cancer. Invest New Drugs. 2015 Feb;33(1):119-27. doi: 10.1007/s10637-014-0161-y. Epub 2014 Sep 23.
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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.
Tadashi Nakanishi study director
Eisai Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E7389 in people with Breast Cancer, run by Eisai Co., Ltd. at 2 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 10 inclusion and 7 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 30 Mar 2015). 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 Participants With Dose Limiting Toxicity (DLT) (time frame: Up to 3 weeks). 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?
On the ClinicalTrials.gov record for NCT01432886, 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 7 Oct 2016.