Clinical trial · Interventional
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
A Phase 1 Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
NCT01432886CI-TRIAL-00024190completedPhase 1Results 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 the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E7389 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: E7389
Primary outcomes (2)
- measure
- Number of Participants With Dose Limiting Toxicity (DLT)
- timeFrame
- Up to 3 weeks
- description
- For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria * Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent. * Histologically or cytologically confirmed with breast cancer * Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method * Subjects who meet any of the following criteria: * Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane * Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane * Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer * Adequate organ function * Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1 * Subjects who have submitted written informed consent for study entry Exclusion Criteria * Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment * Subjects with severe active infection requiring active treatment * Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage. * Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives * Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test. * Subjects who are pregnant (positive B-hCG test) or breastfeeding * Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.
References
Publications (1)
- DERIVEDMukai H, Saeki T, Shimada K, Naito Y, Matsubara N, Nakanishi T, Obaishi H, Namiki M, Sasaki Y. Phase 1 combination study of eribulin mesylate with trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 positive breast cancer. Invest New Drugs. 2015 Feb;33(1):119-27. doi: 10.1007/s10637-014-0161-y. Epub 2014 Sep 23. PMID 25242374