Metastatic Breast CancerPhase 2NCT02581839
Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
A Phase 2 study testing Eribulin Mesylate, MRI and Pre-Medication: Zofran in people with Metastatic Breast Cancer and Brain Metastases, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, Brain Metastases
- What is being tested?
- Eribulin Mesylate, MRI and Pre-Medication: Zofran
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Nov 2015to 2 Jul 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with histologically confirmed breast cancer.
- Patients must have evidence of metastatic disease (non measurable disease is eligible).
- Radiologically confirmed metastatic brain lesion by MRI.
- Brain metastases from breast cancer with or without prior WBRT, STS of surgical resection. Progression must be documented in an at least one lesion untreated by SRS or in any site after surgery or WBRT.
- Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least 1 week prior to obtaining the baseline MRI of the brain, and/or at least 1 week prior to beginning study treatment.
- No presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 months.
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- Patients may not be on any cytotoxic chemotherapy or hormonal treatment for breast cancer during protocol treatment. Trastuzumab is allowed in HER2 positive patients).
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
- Karnofsky performance status ≥ 60
- No brain radiation therapy > 4 weeks
- No chemotherapy for > 3 weeks before planned start of protocol treatment
- Adequate bone marrow, renal, and hepatic function, per local reference laboratory ranges as follows:
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Calculated creatinine clearance (CrCl) ≥ 30mL/min (Cockcroft-Gault method)
- Patients with normal, mild or moderate hepatic dysfunction are eligible.
- Calcium <10.1 mg/dL (corrected to serum albumin as follows: Corrected Calcium = (0.8 x (4 - patient albumin)) + serum Ca
- Females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment
- Able to undergo MRI evaluation with and without gadolinium contrast
Who cannot join
- Patients with the presence of an active infection, abscess or fistula
- Known leptomeningeal disease or CNS midline shifts.
- Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease.
- Severe conduction abnormality including significant QTc prolongation >450ms.
- Patients with grade 3/4 peripheral neuropathy.
- Patients with pacemaker or an ICD devices.
- Previous treatment with eribulin mesylate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but the effect it may or may not have on brain metastases has not been studied.
Read the detailed description
Primary Objectives:
To determine the 3-month central nervous system (CNS)-progression free survival (PFS) for patients with metastatic breast cancer with brain metastases treated with eribulin mesylate.
Secondary Objective(s):
- Estimate CNS complete and partial response rates (CR and PR) and duration of CNS response in this patient population.
2 Evaluate toxicity in patients with breast cancer with brain metastases treated with eribulin mesylate.
3 Estimate clinical benefit rate (CBR) at 3 months in breast cancer patients with brain metastases treated with eribulin mesylate. (CBR is the sum of CR, PR and stable disease at 3 months).
4 To estimate systemic disease (extra cranial) response rate and duration of systemic response in this patient population.
5 Overall survival in this patient population.
Design:
This is a phase II study that will require patients to evaluate the primary objective (CNS PFS at 3 months). Study patients will have a baseline brain MRI and a second MRI at 12 weeks to evaluate disease.
- Conditions
- Metastatic Breast Cancer, Brain Metastases
- Being tested
- Eribulin Mesylate, MRI, Pre-Medication: Zofran, Pre-Medication: Decadron
- Keywords
- eribulin, central nervous system, CNS, Eribulin Mesylate, Halaven
- Medical subject headings
- Breast Neoplasms, Brain 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
Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
MRIDevice
Also called Magnetic Resonance Imaging
An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
Pre-Medication: ZofranDrug
Zofran at 8mg orally. Given at the discretion of the treating physician
Pre-Medication: DecadronDrug
decadron at 8mg orally. Given at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Eribulin Mesylate | Experimental | The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate Receives: Drug: Eribulin Mesylate; Device: MRI; Drug: Pre-Medication: Zofran; Drug: Pre-Medication: Decadron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)
The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Measured: At 12 weeks
Secondary outcomes (6)
Objective Response Rate (RR)
The study team will calculate the percent of participants with complete and partial response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Measured: up to 2 years from start of treatment
Median Duration of CNS Response
The study team will calculate the duration of CNS response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Measured: up to 2 years from start of treatment
Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events
The study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin.
Measured: up to 2 years from start of treatment
Number of Patients With CBR
The study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR)
Measured: At 12 weeks
Systemic Disease Response Rate
The study team will estimate systemic disease response rate (and 95% CI) and perform a Kaplan-Meier analysis for systemic response in this patient population
Measured: up to 2 years from start of treatment
Median Overall Survival (OS)
The study team will generate a Kaplan-Meier curve of OS.
Measured: up to 2 years from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start17 Nov 2015
- Primary completion2 Jul 2018
- Study completion2 Jul 2020
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 Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Silverman, MD, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581839
- Sponsor's protocol ID
- CASE7113
- Status last verified
- Jul 2020
- First submitted
- 14 Oct 2015
- Last updated
- 30 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
- ClinicalTrials.gov ID
- NCT02581839
- Acronym / sponsor ID
- CASE7113
- Conditions
- Metastatic Breast Cancer, Brain Metastases
- Keywords
- eribulin, central nervous system, CNS, Eribulin Mesylate, Halaven
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 3 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but the effect it may or may not have on brain metastases has not been studied.
Detailed description
Primary Objectives:
To determine the 3-month central nervous system (CNS)-progression free survival (PFS) for patients with metastatic breast cancer with brain metastases treated with eribulin mesylate.
Secondary Objective(s):
- Estimate CNS complete and partial response rates (CR and PR) and duration of CNS response in this patient population.
2 Evaluate toxicity in patients with breast cancer with brain metastases treated with eribulin mesylate.
3 Estimate clinical benefit rate (CBR) at 3 months in breast cancer patients with brain metastases treated with eribulin mesylate. (CBR is the sum of CR, PR and stable disease at 3 months).
4 To estimate systemic disease (extra cranial) response rate and duration of systemic response in this patient population.
5 Overall survival in this patient population.
Design:
This is a phase II study that will require patients to evaluate the primary objective (CNS PFS at 3 months). Study patients will have a baseline brain MRI and a second MRI at 12 weeks to evaluate disease.
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 | Experimental | Drug: Eribulin Mesylate, Device: MRI, Drug: Pre-Medication: Zofran, Drug: Pre-Medication: DecadronThe recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study 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 (20 listed)
- Female with histologically confirmed breast cancer.
- Patients must have evidence of metastatic disease (non measurable disease is eligible).
- Radiologically confirmed metastatic brain lesion by MRI.
- Brain metastases from breast cancer with or without prior WBRT, STS of surgical resection. Progression must be documented in an at least one lesion untreated by SRS or in any site after surgery or WBRT.
- Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least 1 week prior to obtaining the baseline MRI of the brain, and/or at least 1 week prior to beginning study treatment.
Key exclusion criteria (7 listed)
- Patients with the presence of an active infection, abscess or fistula
- Known leptomeningeal disease or CNS midline shifts.
- Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease.
- Severe conduction abnormality including significant QTc prolongation >450ms.
- Patients with grade 3/4 peripheral neuropathy.
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: HalavenMost subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. | Drug | Eribulin Mesylate |
| MRIAlso: Magnetic Resonance ImagingAn MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate | Device | Eribulin Mesylate |
| Pre-Medication: ZofranZofran at 8mg orally. Given at the discretion of the treating physician | Drug | Eribulin Mesylate |
| Pre-Medication: Decadrondecadron at 8mg orally. Given at the discretion of the treating physician | Drug | Eribulin Mesylate |
Primary outcome
Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)
Time frame: At 12 weeks
The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
6 secondary outcomes
Objective Response Rate (RR)
Time frame: up to 2 years from start of treatment
Median Duration of CNS Response
Time frame: up to 2 years from start of treatment
Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events
Time frame: up to 2 years from start of treatment
Number of Patients With CBR
Time frame: At 12 weeks
Systemic Disease Response Rate
Time frame: up to 2 years from start of treatment
Median Overall Survival (OS)
Time frame: up to 2 years from start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
Paula Silverman, MD principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
2 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, MRI and Pre-Medication: Zofran in people with Metastatic Breast Cancer and Brain Metastases, run by Case Comprehensive Cancer Center at 2 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 20 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 30 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 2 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 3 Mar 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?
Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS) (time frame: At 12 weeks). 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 30 Jul 2020.