Breast CancerNCT01142661
Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies
A study testing Eribulin Mesylate in people with Breast Cancer, run by Eisai Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator. Read more about this study
- Who is it for?
- Ages 18 years and older, 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
- 9 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2010to Aug 2011
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:
- Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.
- Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:
- Anthracyclines, taxanes, and capecitabine.
- Ixabepilone in countries where this agent is marketed.
- Trastuzumab for Her-2 positive disease.
Show all 32Show fewer
- Hormonal therapy in hormone receptor-positive disease.
- All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Serum creatinine </= 2.0 mg/dL or creatinine clearance >/= 40 mL/min according to Cockcroft and Gault formula.
- Absolute neutrophil count >/= 1.5 x 10^9/L, hemoglobin >/= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L.
- Total bilirubin </= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase </= 3 x ULN (</= 5 x ULN in case of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.
- Are willing and able to comply with all aspects of the treatment protocol.
- Provide written informed consent.
- Females, age >/= 18 years.
- Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomised partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol:
- Eligible for any other eribulin study that is open in the same region.
- Existing anti-cancer therapy-related toxicities of Grade >/= 2, except that alopecia and Grade 2 neuropathy are acceptable.
- History of congestive heart failure with New York Heart Association Classification >II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia.
- Electrocardiogram with QTc interval >/= 500 msec based upon Bazett's formula (QTcB).
- The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason.
- Females who are pregnant (positive B-hCG test) or breastfeeding.
- Subject with hypersensitivity to eribulin or any of the excipients.
- 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 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol.
- Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol.
- Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.
- Subjects with meningeal carcinomatosis.
- Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
- Subjects who have received any of the following treatments within the specified period before the start of treatment:
- Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks.
- Hormonal therapy within 1 week.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Bismarck, North Dakota
Study site
Dallas, Texas
Study site
La Verne, California
Study site
Nyack, New York
Study site
Raleigh, North Carolina
About this study
The purpose of this study is to provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator.
Read the detailed description
This compassionate use program will consist of a Pretreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria may be treated. Safety data will be collected, but a minimal amount of other data will also be collected.
- Conditions
- Breast Cancer
- Being tested
- Eribulin Mesylate
- Keywords
- Advanced breast cancer refractory to all commercially available therapies
- 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
Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
| 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.
Safety
General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Measured: For duration of treatment, an average of 5 months
Safety
General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Measured: For duration of treatment, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionAug 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eisai Medical Services, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142661
- Sponsor's protocol ID
- E7389-G000-399
- Status last verified
- Sep 2013
- First submitted
- 10 Jun 2010
- Last updated
- 20 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies
- ClinicalTrials.gov ID
- NCT01142661
- Acronym / sponsor ID
- E7389-G000-399
- Conditions
- Breast Cancer
- Keywords
- Advanced breast cancer refractory to all commercially available therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Posted 20 Sep 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 is to provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator.
Detailed description
This compassionate use program will consist of a Pretreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria may be treated. Safety data will be collected, but a minimal amount of other data will also be collected.
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
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:
- Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.
- Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Serum creatinine </= 2.0 mg/dL or creatinine clearance >/= 40 mL/min according to Cockcroft and Gault formula.
Key exclusion criteria (0 listed)
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: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death. | Drug | Eribulin mesylate |
Primary outcome
Safety
Time frame: For duration of treatment, an average of 5 months
General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Safety
Time frame: For duration of treatment, an average of 5 months
General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 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.
Eisai Medical Services study director
Eisai Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eribulin Mesylate in people with Breast Cancer, run by Eisai Inc. at 5 sites in United States.
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 32 inclusion and 0 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 20 Sep 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 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?
Safety (time frame: For duration of treatment, an average of 5 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 20 Sep 2013.