Recurrent Breast CarcinomaPhase 2NCT01908101
Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer
A Phase 2 study testing Eribulin Mesylate and Laboratory Biomarker Analysis in people with Recurrent Breast Carcinoma and Stage IV Breast Cancer, run by University of Washington at 12 sites in United States.
Trial summary
This phase II trial studies how well eribulin mesylate works in treating patients with previously treated breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Breast Carcinoma, Stage IV Breast Cancer
- What is being tested?
- Eribulin Mesylate and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 12 sitesUnited States
- Study dates
- 8 Jan 2014to 4 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent
- Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
- At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients must have baseline imaging within 30 days prior to the start of therapy and satisfy one of the following:
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
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- At least one non lymph node lesion of >= 1.0 cm or lymph node >= 1.5 cm in short axis by computerized tomography (CT) scan (CT scan thickness no greater than 5 mm which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)
- Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion
- Non-measurable disease by RECIST 1.1 criteria (includes bone only disease and lesions < 10 mm or lymph nodes < 15 mm in short axis) with rising serum CA15-3 or CA 27.29 or CEA documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration. The second CA 15-3 or CA 27.29 value must have at least a 20% increase over the first and for CA 15-3 or CA27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
- Absolute neutrophil count >= 1,500/mm^3
- Hemoglobin >= 10 g/dL
- Platelets >= 100,000/mm^3
- Creatinine =< 1.5 x upper limit of normal (ULN)
- Total bilirubin =< 1.5 x ULN
- Alkaline phosphatase =< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone metastases in the absence of liver metastases
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal, unless due to liver metastases (=< 5 x ULN)
- Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
- Life expectancy of > 12 weeks
Who cannot join
- Prior treatment with eribulin
- Plan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:
- Trastuzumab at standard dosing human epidermal growth factor receptor 2 (HER2) positive tumors
- Denosumab or bisphosphonates to treat metastatic bone disease
- Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment
- Patients with known central nervous system (CNS) metastases must have stable disease off steroids after treatment with surgery or radiation therapy
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- Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
- Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance [CrCl] 30-50 mL/min) renal impairment
- Radiotherapy within 14 days of study treatment
- Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
- Treatment with any systemic chemotherapy or investigational agents within 3 weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy
- Patients with peripheral neuropathy > grade 2 regardless of etiology
- Significant cardiovascular impairment: congestive heart failure > class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (> grade 2)
- Concomitant severe or uncontrolled medical disease
- Significant psychiatric or neurologic disorder which would compromise participation in the study
- Pregnant or breast-feeding females
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Bend Memorial Clinic
Bend, Oregon, 97701
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Skagit Valley Hospital
Mount Vernon, Washington, 98274
Olympic Medical Center
Port Angeles, Washington, 98362
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Group Health Cooperative-Seattle
Seattle, Washington, 98112
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
About this study
Official title: Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer (MBC)
This phase II trial studies how well eribulin mesylate works in treating patients with previously treated breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Read the detailed description
PRIMARY OBJECTIVES:
- Progression free survival (PFS).
SECONDARY OBJECTIVES:
- Frequency of alopecia with absence or decrease to < 50%.
II. Incidence of grade 3 and 4 neutropenia of < 30%.
III. Incidence of sensory neuropathy (all grades) to < 25%.
TERTIARY OBJECTIVES:
- Assess the role of circulating endothelial cell precursors (CEPs) and apoptotic circulating endothelial cells (CECs), in predicting early response to treatment.
OUTLINE:
Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
- Conditions
- Recurrent Breast Carcinoma, Stage IV Breast Cancer
- Being tested
- Eribulin Mesylate, Laboratory Biomarker Analysis
- 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 B1939 Mesylate, E7389, ER-086526, Halaven
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (eribulin mesylate) | Experimental | Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Eribulin Mesylate; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Kaplan-Meier survival curves will be used to describe PFS, overall and stratified by number of prior metastatic treatment regimens. A 95% confidence interval for the median PFS will be calculated using the method of Brookmeyer and Crowley.
Measured: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study start8 Jan 2014
- Primary completion4 May 2019
- Study completion4 May 2019
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 Recurrent Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hannah Linden, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908101
- Sponsor's protocol ID
- 8093
- Other IDs
- NCI-2013-01326, 8093, P30CA015704
- Status last verified
- May 2020
- First submitted
- 19 Jul 2013
- Last updated
- 23 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT01908101
- Acronym / sponsor ID
- 8093
- Conditions
- Recurrent Breast Carcinoma, Stage IV Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jan 2014 (actual)
- Primary completion
- 4 May 2019 (actual)
- Study completion
- 4 May 2019 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Posted 23 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well eribulin mesylate works in treating patients with previously treated breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed description
PRIMARY OBJECTIVES:
- Progression free survival (PFS).
SECONDARY OBJECTIVES:
- Frequency of alopecia with absence or decrease to < 50%.
II. Incidence of grade 3 and 4 neutropenia of < 30%.
III. Incidence of sensory neuropathy (all grades) to < 25%.
TERTIARY OBJECTIVES:
- Assess the role of circulating endothelial cell precursors (CEPs) and apoptotic circulating endothelial cells (CECs), in predicting early response to treatment.
OUTLINE:
Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (eribulin mesylate) | Experimental | Drug: Eribulin Mesylate, Other: Laboratory Biomarker AnalysisPatients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Ability to provide written informed consent
- Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
- At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients must have baseline imaging within 30 days prior to the start of therapy and satisfy one of the following:
Key exclusion criteria (16 listed)
- Prior treatment with eribulin
- Plan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:
- Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment
- Patients with known central nervous system (CNS) metastases must have stable disease off steroids after treatment with surgery or radiation therapy
- Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
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: B1939 Mesylate, E7389, ER-086526, HalavenGiven IV | Drug | Treatment (eribulin mesylate) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (eribulin mesylate) |
Primary outcome
PFS
Time frame: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year
Kaplan-Meier survival curves will be used to describe PFS, overall and stratified by number of prior metastatic treatment regimens. A 95% confidence interval for the median PFS will be calculated using the method of Brookmeyer and Crowley.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- 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.
Hannah Linden principal investigator
Fred Hutch/University of Washington Cancer Consortium
12 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 and Laboratory Biomarker Analysis in people with Recurrent Breast Carcinoma and Stage IV Breast Cancer, run by University of Washington at 12 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 18 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
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 23 Jul 2020). 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?
PFS (time frame: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year). 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 23 Jul 2020.