Eribulin in Brain Metastases From HER2-negative Breast Cancer (NCT03637868) | Clinical Trial Compass
WithdrawnPhase 2
Eribulin in Brain Metastases From HER2-negative Breast Cancer
Stopped: no enrollment
France0Started 2019-02-26
Plain-language summary
To evaluate the efficacy of eribulin for treatment of HER2-negative breast cancer brain metastases (BCBM)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 18 years of age.
. Life expectancy of 3 months or longer.
. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2.
. HER2-negative (IHC 0/1+ or 2+ and in situ hybridization negative) metastatic breast cancer
. Locally advanced or metastatic breast cancer that have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. (no limit to the number of previous lines of therapy, no need for extracranial disease)
. At least 2 weeks washout period post chemotherapy, targeted or biologic therapy, or radiation therapy is required prior to study entry
. Patient with untreated CNS disease or previous SRS/surgery without WBRT (cohorts A and B)
. Patient with progressive disease harboring brain metastases after previous WBRT (cohort C)
Exclusion criteria
. Prior therapy with eribulin.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of eribulin for treatment of HER2-negative BCBM
Timeframe: from inclusion until 30 days after completion of treatment
. Patients should not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. (Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period)
. Patients may not have the following co morbid disease or concurrent illness:
. Patient candidate to SRS and or surgical resection
. Major clinical symptoms requiring immediate WBRT as defined by "local tumor board"
. Increase in corticosteroid dose in the week prior to baseline brain MRI
. Patients with pacemaker or implantable cardioverter-defibrillator devices incompatible with MRI assessment.