Adults 18 to 100, any sex, with HER2-normal. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With FeasibilityPrimary· From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months
The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collectively counted as one entity in the same participant. Participants were followed for approximately 3
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
70.4
58.5 – 80.4
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
60.0
41.7 – 76.4
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs)Secondary· From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months
Safety assessments consisted of monitoring and recording all AEs and SAEs, clinical laboratory results, vital signs, physical examinations, Eastern Cooperative Oncology Group (ECOG) performance status, electrocardiograms (ECGs), and left-ventricular ejection fracture (LVEF) by multigated acquisition scan (MUGA) or echocardiogram. An AE was considered a treatment emergent adverse event (TEAE) if the AE onset date was on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related TEAEs included TEAEs that were considered by the Investiga
All TEAEs
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
55
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
26
AC-related TEAEs
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
55
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
26
Eribulin-related TEAEs
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
54
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
23
Grade ≥3 TEAEs
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
31
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
18
SAEs
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
6
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
4
Alopecia
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
40
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
19
Neutropenia (SMQ)
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
20
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
11
Peripheral neuropathy (SMQ)
Group
Value
95% CI
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
40
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
15
Adverse events — posted to ClinicalTrials.gov
Time frame: From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1: Eribulin Mesylate With Filgrastim as Needed
Serious: 6/55 (11%)
Deaths: 3/55
Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02120469 — Eribulin Mesylate and Everolimus in Treating Patients With Triple-Negative Metastatic Breast Cancer
· Phase 1
· completed
NCT01676818 — Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
· Phase 2
· completed
NCT01613768 — Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
· Phase 2
· completed
NCT01126736 — Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second Line Therapy in Patients
· Phase 1, PHASE2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 20 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01328249.