18 and older, female only, with Metastatic Breast Cancer. 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 Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of EfficacyPrimary· Up to 2 years
The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Cohort A: Triple-negative Breast Cancer Patients
56
42 – 69
Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients
83
67 – 91
Cohort C: HER2-positive Breast Cancer Patients
73
53 – 86
Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment FeasibilitySecondary· up to 18 weeks
Examines the feasibility of administering 6 cycles (21 days per cycle) of eribulin without toxicity or disease worsening following standard neoadjuvant chemotherapy and surgery.
Group
Value
95% CI
Cohort A: Triple-negative Breast Cancer Patients
46
Cohort B: ER/PR Positive/HER2-negative Breast Cancer
34
Cohort C: HER2-positive Breast Cancer Patients
26
The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of SafetySecondary· Weekly during each 21 day cycle and for 30 days after completion of protocol-specific treatment. After that patients were followed every 3 months for up to 2 years.
A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.
Group
Value
95% CI
Cohort A: Triple-negative Breast Cancer Patients
50
Cohort B: ER/PR Positive/HER2-negative Breast Cancer
41
Cohort C: HER2-positive Breast Cancer Patients
31
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 and Day 8 of every treatment cycle and 30 days after discontinuation or completion of treatment for up to 22.2 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A: Triple-negative Breast Cancer
Serious: 8/53 (15%)
Deaths: 6/53
Cohort B: ER/PR Positive/HER2-negative Breast Cancer
Serious: 1/42 (2%)
Deaths: 4/42
Cohort C: HER2 Positive Breast Cancer
Serious: 3/31 (10%)
Deaths: 1/31
Serious adverse events (12 terms)
Reaction
System
Cohort A: Triple-negative …
Cohort B: ER/PR Positive/H…
Cohort C: HER2 Positive Br…
Cardiac failure congestive
Cardiac disorders
—
—
—
Cellulitis
Infections and infestations
—
—
—
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
Hyperglycaemia
Metabolism and nutrition disorders
—
—
—
Mastitis
Infections and infestations
—
—
—
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat
· Phase 2
· not yet recruiting
NCT07461454 — YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer
· Phase 3
· not yet recruiting
NCT06957431 — Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma
· Phase 1
· recruiting
NCT06942234 — Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer
· Phase 1, PHASE2
· recruiting
NCT06102824 — Organoid-based Functional Precision Therapy for Advanced Breast Cancer
· Phase 2
· recruiting
Other recruiting trials for Metastatic Breast Cancer
Currently open trials in the same condition.
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· recruiting
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· Phase 1
· recruiting
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· NA
· recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated,
· recruiting
Other SCRI Development Innovations, LLC trials
Trials by the same sponsor.
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· Phase 2
· completed
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· completed
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· terminated
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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 SCRI Development Innovations, LLC
Last refreshed: 15 June 2018
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/NCT01401959.