Researchers seek 910 women or men with stage IIIC or stage IV breast cancer for a phase III study. The trial will include people starting treatment for the first time as well as those who had previous treatment that didn’t work or stopped working.
The trial team will test whether eribulin mesylate (Halaven) is a more effective chemotherapy treatment than standard weekly paclitaxel (Taxol).
Background and Goals
Eribulin mesylate was approved by the U.S. Food and Drug Administration in 2010 for people who already received at least two other medicines for breast cancer once it has metastasized, or spread. This trial examines whether giving this medicine earlier in the treatment of advanced breast cancer extends life more than the standard treatment.
The trial team will compare the overall survival of people taking eribulin mesylate with that of people taking paclitaxel, one of the standard therapies. Overall survival is the time from the start of the trial treatment to death from any cause.
The team will also measure progression-free survival, or PFS. PFS is the length of time after receiving the study medicine that the disease is still present but does not grow. They will monitor tumor size from the start of the study until death and whether and how often severe side effects occur.
Participants will continue treatment until disease progresses, side effects become unacceptable or you or your doctor decide it is best to leave the trial.
Participants will be followed for up to 4 years. If you stop trial treatment earlier but the cancer shows no signs of growth on imaging tests, the researchers will continue to follow you with imaging studies every 12 weeks until the disease starts to grow again.
This study is open-label, which means you and your doctor will know which medicine you are taking. Participants will be equally divided between two treatment groups based on factors including the cancer’s hormone receptor status and whether this is your first treatment for advanced disease, or your second.
One group will receive eribulin on days 1 and 8 of each 21-day cycle. The other will receive paclitaxel on days 1, 8 and 15 of each 28-day cycle.
You may be able to take part if you
- are age 18 or older.
- have progressing stage IV disease, or stage IIIC disease that cannot be treated with surgery or radiation therapy.
- have HER2-negative breast cancer at the time of registration.
- have a life expectancy of more than 12 weeks.
- are willing to provide blood and tissue samples.
You may not be eligible if you
- have ever taken eribulin mesylate.
- have had more than one prior chemotherapy for your metastatic disease.
- are pregnant or nursing. The medicines may harm an unborn baby.
- have a serious non-healing wound, ulcer or bone fracture.
- have HIV.
- have had a stroke or “mini-stroke” (transient ischemic attack, TIA) less than 6 months before registration.
- have significant heart disease (recent heart attack less than 6 months earlier, or a serious heart rhythm problem) or heart failure.
- have a history of uncontrolled seizures.
For more information or to find out if you are eligible, talk with your doctor about trial NCT02037529 on ClinicalTrials.gov.
This study is being conducted in 33 locations in the U.S. Some sites are recruiting now and others will recruit later. For full details and contact information, visit ClinicalTrials.gov.