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NCT02581839

Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

Completed Phase 2 Results posted Last updated 30 July 2020
What this trial tests

Phase 2 trial testing Eribulin Mesylate in Metastatic Breast Cancer in 9 participants. Completed in 2 July 2020.

Timeline
17 November 2015
Primary endpoint
2 July 2018
2 July 2020

Quick facts

Lead sponsorCase Comprehensive Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date17 November 2015
Primary completion2 July 2018
Estimated completion2 July 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

18 and older, female only, with Metastatic Breast Cancer or Brain Metastases. 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.

Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS) Primary · At 12 weeks

The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.

GroupValue95% CI
Eribulin Mesylate88.951 – 99.7
Objective Response Rate (RR) Secondary · up to 2 years from start of treatment

The study team will calculate the percent of participants with complete and partial response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.

GroupValue95% CI
Eribulin Mesylate11.1
Median Duration of CNS Response Secondary · up to 2 years from start of treatment

The study team will calculate the duration of CNS response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.

GroupValue95% CI
Eribulin Mesylate22.64.3 – 31.9
Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events Secondary · up to 2 years from start of treatment

The study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin.

GroupValue95% CI
Eribulin Mesylate3
Number of Patients With CBR Secondary · At 12 weeks

The study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR)

GroupValue95% CI
Eribulin Mesylate5
Median Overall Survival (OS) Secondary · up to 2 years from start of treatment

The study team will generate a Kaplan-Meier curve of OS.

GroupValue95% CI
Eribulin Mesylate15.74.0 – 27.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days after treatment has been discontinued, an average of 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Eribulin Mesylate
Serious: 3/9 (33%)
Deaths: 7/9

Serious adverse events (10 terms)

ReactionSystemEribulin Mesylate
Febrile neutropeniaBlood and lymphatic system disorders
FatigueGeneral disorders
Lung infectionInfections and infestations
Neutrophil count decreasedInvestigations
Platelet count decreasedInvestigations
White blood cell decreasedInvestigations
Pain in extremityMusculoskeletal and connective tissue disorders
worsening pseudomeningeoceleNervous system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Thromboembolic eventVascular disorders
Other adverse events (90 terms — click to expand)

ReactionSystemEribulin Mesylate
FatigueGeneral disorders
AnemiaBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
White blood cell decreasedInvestigations
NauseaGastrointestinal disorders
Lymphocyte count decreasedInvestigations
DiarrheaGastrointestinal disorders
Platelet count decreasedInvestigations
Pain in extremityMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
Peripheral sensory neuropathyNervous system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
AlopeciaSkin and subcutaneous tissue disorders
Mucositis oralGastrointestinal disorders
Edema limbsGeneral disorders
Alanine aminotransferase increasedInvestigations
Neutrophil count decreasedInvestigations
HyperglycemiaMetabolism and nutrition disorders
DysgeusiaNervous system disorders
Memory impairmentNervous system disorders
InsomniaPsychiatric disorders
CoughRespiratory, thoracic and mediastinal disorders
HypertensionVascular disorders
Dry mouthGastrointestinal disorders
VomitingGastrointestinal disorders
Gait disturbanceGeneral disorders
MalaiseGeneral disorders
Non-cardiac chest painGeneral disorders
FallInjury, poisoning and procedural complications
Alkaline phosphatase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
AnorexiaMetabolism and nutrition disorders
HypoalbuminemiaMetabolism and nutrition disorders
HypocalcemiaMetabolism and nutrition disorders
HypomagnesemiaMetabolism and nutrition disorders
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
Peripheral motor neuropathyNervous system disorders
HoarsenessRespiratory, thoracic and mediastinal disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Febrile neutropenia, Fatigue, Lung infection, Neutrophil count decreased, Platelet count decreased, White blood cell decreased, Pain in extremity, worsening pseudomeningeocele.

Data from ClinicalTrials.gov NCT02581839 adverse events section.

Sponsor's own description

Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but the effect it may or may not have on brain metastases has not been studied.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Investigational chemotherapy and novel pharmacokinetic mechanisms for the treatment of breast cancer brain metastases.
    Shah N, Mohammad AS, Saralkar P, Sprowls SA, et al · · 2018 · cited 102× · PMID 29604436 · DOI 10.1016/j.phrs.2018.03.021
  2. Understanding patterns of brain metastasis in breast cancer and designing rational therapeutic strategies.
    Brosnan EM, Anders CK. · · 2018 · cited 98× · PMID 29911111 · DOI 10.21037/atm.2018.04.35
  3. Breast cancer brain metastasis: Current evidence and future directions.
    Sun H, Xu J, Dai S, Ma Y, et al · · 2023 · cited 46× · PMID 35822637 · DOI 10.1002/cam4.5021
  4. Evolving treatment strategies of brain metastases from breast cancer: current status and future direction.
    Kim JS, Kim IA. · · 2020 · cited 32× · PMID 32636942 · DOI 10.1177/1758835920936117
  5. Management of Brain and Leptomeningeal Metastases from Breast Cancer.
    Pellerino A, Internò V, Mo F, Franchino F, et al · · 2020 · cited 19× · PMID 33198331 · DOI 10.3390/ijms21228534
  6. Efficacy of eribulin in breast cancer: a short report on the emerging new data.
    Eslamian G, Wilson C, Young RJ. · · 2017 · cited 8× · PMID 28243113 · DOI 10.2147/ott.s102638

Verify or expand the search:

Other trials of Eribulin Mesylate

Trials testing the same drug.

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

Other Case Comprehensive Cancer Center trials

Trials by the same sponsor.

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