Phase 2
Completed N=104
A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00879086 ↗Enrolled (actual)
104
Serious AEs
35.6%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs) — 33.3; 50.0 Percentage of participants — p==0.0941
Summary
The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Neuropathy Adverse Events (AEs) |
33.3; 50.0 | =0.0941 |
| SECONDARY Percentage of Participants With an Incidence of Treatment-emergent Myalgia/Arthralgia |
19.6; 38.0 | 0.0492 sig |
| SECONDARY Change From Baseline in Vibration Perception Threshold (VPT) |
1.50; 1.96; 0.13; -0.09; 0.31; -0.22 | — |
| SECONDARY Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 1 (Sensory) |
8; 7; 9; 3; 5; 4 | — |
| SECONDARY Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Score for Item 2 (Motor) |
8; 12; 12; 3; 8; 6 | — |
| SECONDARY Number of Participants With Shift From Baseline to Worst Post-baseline Participant Neurotoxicity Questionnaire (PNQ) Composite Score |
3; 5; 6; 1; 5; 2 | — |
| SECONDARY Objective Response Rate (ORR) |
15.4; 5.8 | — |
| SECONDARY Progression-Free Survival (PFS) |
104; 95 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
26.9; 21.2 | — |
| SECONDARY Duration of Response (DoR) |
169; NA | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Eribulin and Ixabepilone |
100.0; 100.0; 37.3; 34.0 | — |
Eligibility Criteria
Inclusion criteria
- Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease.
Exclusion criteria
- Subjects who have received prior ixabepilone therapy.
- Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.
- Subjects with pre-existing neuropathy Grade greater than or equal to 2.
- Subjects with a history of diabetes mellitus Type 1 or 2.
- Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.
- Subjects with missing digits required for vibration assessment.
- Subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.
Data sourced from ClinicalTrials.gov (NCT00879086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.