Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer
Status:
Completed
Trial end date:
2019-06-17
Target enrollment:
Participant gender:
Summary
Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective
chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the
preferred chemotherapeutic regimens for patients with MBC, and was found to be proper as a
maintenance chemotherapy regimen with survival benefit and feasible toxicity profile as shown
in a large phase III KCSG (Korean Cancer Study Group) study (Park Y et al. J Clin Oncol
31(14):1732, 2013).
Eribulin mesylate is a microtubule-targeting agent that showed improved overall survival
benefit as monotherapy for MBC patients as a new chemotherapeutic agent after failure of
anthracycline and taxane in EMBRACE study (Cortes J et. al. Lancet 377:914-923, 2011).
Eribulin was also reported its promising efficacy in another randomized phase III study that
demonstrated eribulin as efficacious as capecitabine (Kaufman P et. al. Abstr# S6-6, SABCS
2012). Both study results showed potential clinical benefit in patients with triple negative
MBC (TNBC). Thus, eribulin combined with gemcitabine may be a new potential regimen for early
line therapy in patients with metastatic breast cancer.
Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of
neurotoxicity. Although there is no direct evidence that eribulin has better neurotoxicity
profile than taxane, eribulin tended to show less neurotoxicity compared with ixabepilone in
a phase II trial (Vahdat, L et al. 2011 SABCS). Eribulin has no worsen toxicity as compared
to paclitaxel. Therefore, EG may have less neurotoxicity comparing to PG.
In phase I trial, eribulin in combination with gemcitabine was feasible in patients with
advanced solid tumor treated with chemotherapy (< 3 lines) (Goel R, et al, 2009 ASCO).
Based on this rationale, the investigators are to conduct randomized phase II study comparing
EG chemotherapy with PG chemotherapy for patients with HER-2 negative MBC as first-line
chemotherapy.
A total of 118 patients will be recruited. Patients will be randomized to a treatment arm by
permutated method. The randomization ratio is 1:1. This study is multi-center, randomized,
open label study.
Phase:
Phase 2
Details
Lead Sponsor:
Asan Medical Center
Collaborators:
Dong-A ST Co., Ltd. Eisai Inc. Samyang Biopharmaceuticals Corporation