Alternative Drug Names:
Eribulin is also known as Halaven (US brand name) and previously known as B1939 mesylate. “AC” is short for adriamycin and cyclophosphamide. Doxorubicin is another name for Adriamycin. Cyclophosphamide may also be called Cytoxan (brand name).
Purpose of Trial:
The trial goal is to determine the efficacy changing taxol to eribulin as part of pre-operative (before surgery) therapy for HER2-negative IBC. The main endpoint is the rate of pCR (pathological complete response) which means all the cancer in the mastectomy is dead. Also since eribulin is not approved for non-metastatic disease, the safety in this setting will be recorded.
Why this study is relevant for IBC patients:
Chemotherapy is a mandatory first step in IBC. Currently the standard of care for HER2-negative IBC is a regimen consisting of a taxane and an anthracycline e.g. taxol then AC. Eribulin is being tested since it works by a similar mechanism as a taxane, and in the metastatic setting has efficacy in patients with cancers that are resistant to taxanes.
Eribulin is a standard of care chemotherapy for metastatic breast cancer. Unlike other chemotherapies eribulin may eliminate the cancer stem cells which are thought to be responsible for resistance to treatment and subsequent metastasis. Its use in non-metastatic IBC is investigational. “AC” is a standard anthracycline-containing regimen used in breast cancers including IBC.
This is a single arm phase 2 study where everyone will receive the actual drugs and start at the same doses. The eligibility criteria include definitive IBC diagnosis, no prior treatment for this cancer, HER2-negative status (and ER and PR status is allowed) and adequate organ and blood cell counts. No distant metastasis is allowed either in organs or bone, but bilateral breast cancer is allowed as long as at least 1 breast has the symptoms of IBC.
Eribulin is a short push infusion given on days 1 and 8 of a 21 day cycle, which is repeated for 4 cycles. AC is given as an IV infusion every 3 weeks for 4 cycles. After the completion of this treatment if you have responded at least partially, you will have surgery which is a modified radical mastectomy with axillary node dissection (all axillary lymph nodes removed).
Location of Trial:
Only open at Dana Farber Cancer Institute in Boston, MA (NCI Comprehensive Cancer Center).
For more information:
Contact the principal investigator, Dr Beth Overmoyer at 617-632-6157
Is this study NCI Compliant?:
NCT trial number & link:
NCT02623972 click for more info
Poster from scientific meeting: