Clinical trial · Interventional
Eribulin in HER2 Negative Metastatic BrCa
A Phase 2 Study of Eribulin in Patients With HER2-Negative, Metastatic Breast Cancer: Evaluation of Efficacy, Toxicity and Patient-Reported Outcomes
- 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)
Improvements in outcomes with metastatic breast cancer (MBC) have been observed in the last 30 years, however, overall prognosis remains poor with median survival of 2 to 3 years. Long term complete responses are observed only for a minority of MBC patients (2-5%) and MBC remains an incurable disease for most patients. Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with MBC who have received at least two prior chemotherapy regimens. In this research study, the investigators are looking to see how well eribulin helps participants with MBC in an earlier-line setting. Eribulin works by interfering with cancer cell division, growth and spread.
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 |
|---|---|---|---|
| Eribulin | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1: HR+/HER2-
- description
- Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.
- interventionNames
- Drug: Eribulin
- type
- EXPERIMENTAL
- label
- Cohort 2: TNBC
- description
- Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.
- interventionNames
- Drug: Eribulin
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven invasive breast cancer, locally recurrent or metastatic, with at least one measureable lesion according to RECIST v1.1 * Hormone receptor positive or hormone receptor negative HER2-negative disease * Up to one prior line of chemotherapy for advanced disease is allowed (discontinued at least 14 days prior to initiation of protocol therapy) * Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable * No limit on prior lines of endocrine therapy, but must be discontinued at least 7 days prior to initiation of protocol therapy * Must have completed any prior radiotherapy at least 2 weeks prior to initiation of protocol therapy * Must have recovered from reversible effects of prior therapies to no more than grade 1 toxicity, with the exception of alopecia * Agree to use adequate contraception for the duration of study participation Exclusion Criteria: * Pregnant or breastfeeding * Prior treatment with eribulin * Prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer unless diagnosed and definitively treated at least 3 years before enrollment in this study * Clinically significant cardiovascular impairment * Active brain metastases or unevaluated neurologic symptoms suggestive of brain metastases * Pulmonary dysfunction requiring the use of oxygen * Prior organ allograft requiring immunosuppression * HIV positive on combination antiretroviral therapy * Pre-existing grade 3 or 4 neuropathy * Hypersensitivity to halichondrin B or halichondrin B chemical derivative * Uncontrolled intercurrent illness * Inability to read in English
References
Publications (1)
- DERIVEDFilho OM, Giobbie-Hurder A, Lin NU, Faggen M, Come S, Openshaw T, Constantine M, Walsh J, Freedman RA, Schneider B, Burstein HJ, Mayer EL. A dynamic portrait of adverse events for breast cancer patients: results from a phase II clinical trial of eribulin in advanced HER2-negative breast cancer. Breast Cancer Res Treat. 2021 Jan;185(1):135-144. doi: 10.1007/s10549-020-05928-4. Epub 2020 Oct 6. PMID 33025482