Clinical trial · Interventional
A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
A Phase 2, Multicenter, Single-Arm Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
NCT01268150CI-TRIAL-00067332completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Recurrent | — | UNRESOLVED | — |
| Metastatic Breast Cancer ( HER2 Negative) | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin mesylate | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- interventionNames
- Drug: Eribulin mesylate
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years
- description
- The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria Females age 18 years or older at the time of informed consent Have histologically or cytologically proven adenocarcinoma of the breast Subjects with locally recurrent or metastatic disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1 Human epidermal growth factor receptor (HER2)-negative disease as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining. Life expectancy of greater than 24 weeks Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2 At least 12 months since prior neoadjuvant or adjuvant chemotherapy At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery from the effects of these interventions Adequate renal function Adequate bone marrow function Adequate liver function Key Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in this study: Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic breast cancer Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer Prior exposure of greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 mg/m2 epirubicin Inflammatory breast cancer Clinically significant cardiovascular impairment Subjects with known CNS disease are not eligible, except for those with treated brain metastasis. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen Currently pregnant or breast-feeding. Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade 2 before enrollment.
References
Publications (1)
- DERIVEDMcIntyre K, O'Shaughnessy J, Schwartzberg L, Gluck S, Berrak E, Song JX, Cox D, Vahdat LT. Phase 2 study of eribulin mesylate as first-line therapy for locally recurrent or metastatic human epidermal growth factor receptor 2-negative breast cancer. Breast Cancer Res Treat. 2014 Jul;146(2):321-8. doi: 10.1007/s10549-014-2923-9. Epub 2014 Apr 4. PMID 24699910