A phase II, multicenter, single-arm trial of eribulin as first- or second-line chemotherapy for HER2-negative advanced or metastatic breast cancer: evaluation of efficacy, safety, and patient-reported outcomes
Although eribulin is a suitable option for early-line treatment of metastatic breast cancer (MBC), data on first- or second-line use of eribulin for human epidermal growth factor receptor 2 (HER2)-negative MBC are still limited. Therefore, we conducted a phase II trial to investigate the efficacy and safety of eribulin for first- or second-line chemotherapy for HER2-negative MBC.
Materials and methods
We performed a phase II, open-label, single-arm, multicenter study in Japan. Eligible patients were women with histologically confirmed HER2-negative MBC without chemotherapy or only one chemotherapy line for MBC. The primary endpoint was the overall response rate (ORR) and the secondary endpoints included the clinical benefit rate (ORR + stable disease for 6 months; CBR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), safety, and health-related quality of life (HRQoL).
A total of 35 patients with HER2-negative MBC were enrolled between March 2013 and February 2017 (data cut-off July 31, 2017). The ORR was 37.1% (95% CI 21.1–53.2%). The CBR was 54.3% (95% CI 37.8–70.8%). The median PFS was 6.2 months (95% CI 2.7–9.4 months) and median OS was 21.4 months (95% CI 11.5–32.9 months). Common grade 3/4 adverse events were neutropenia (42.9%) but febrile neutropenia (2.9%). Although the majority of non-hematological adverse events were mild in severity, one patient died of pneumonitis. In HRQoL analysis, eribulin appeared to maintain HRQoL of many patients.
Eribulin as first- or second-line chemotherapy is effective and has manageable toxicity for patients with HER2-negative MBC.
KeywordsEribulin Metastatic breast cancer First or second-line Objective response rate QOL
The authors would like to express their gratitude to the patients who participated in this trial and their family members, and to the investigators and all staff members at the study sites for their contribution to the study. This is an investigator-initiated clinical trial and was not supported by any industry funding. We thank Ellen Knapp, PhD, from Edanz Group (http://www.edanzediting.com/ac) for editing a draft of this manuscript.
Compliance with ethical standards
Conflict of interest
All authors declare that we have no conflict of interest.
All procedures performed in studies involving human participants were approved by the local ethics committees or the institutional review board at each study site. This trial was conducted in accordance with the Japanese Guidelines for Clinical Research from the Ministry of Health, Labour and Welfare and the Declaration of Helsinki, as well as other applicable regulatory requirements.
All participants provided written informed consent prior to study entry.
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