Clinical trial · Interventional
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients
A Multicenter, Randomized, Phase II Trial Evaluating the Efficacy of Eribulin Monotherapy and Eribulin Plus Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients After Progression on Endocrine Therapy (REVERT)
NCT03795012CI-TRIAL-00053596terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment rate
Summary
Brief summary (as posted)
Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).
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
- ACTIVE_COMPARATOR
- label
- Eribulin monotherapy
- description
- Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle
- interventionNames
- Drug: Eribulin
- type
- ACTIVE_COMPARATOR
- label
- eribulin plus endocrine therapy
- description
- Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle, in combination with endocrine therapy (aromatase inhibitor). AI must be identical to the last AI administered to the patient, whether in the adjuvant or metastatic setting.
- interventionNames
- Drug: Eribulin
Primary outcomes (1)
- measure
- The overall response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ER-positive and/or PR-positive breast cancer. * HER2-negative breast cancer. * Unresectable locally advanced or metastatic breast cancer. * Confirmed disease progression while in the last aromatase inhibition-containing regimen in the metastatic setting. * At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting. * Patients with no prior line of chemotherapy in the metastatic setting. * At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting. * ECOG score 0 or 1. * Patients have adequate bone marrow and organ function. * Patients must have measurable disease (RECIST v.1.1). * Premenopausal with LHRH analogues for at least 28 days) and postmenopausal women. * Patients must agree to not breastfeed during the study and for 3 months after the last dose of study treatment. * Life expectancy greater or equal to 12 weeks. * Patients agree to collection of blood samples (liquid biopsy) and optional collection of metastatic tumour sample (biopsy) at the time of inclusion and progression (if appropriate). Exclusion Criteria: * Have received radiation therapy or limited-field palliative radiotherapy within two weeks prior to Cycle 1, Day 1, or patients who have not recovered from radiotherapy-related toxicities. * Have received prior chemotherapy for locally advanced or metastatic disease. * Have peripheral neuropathy grade 2 or greater. * QTc \> 480 msec on basal assessments, history of congenital or personal history of long QT syndrome, Brugada syndrome, or Torsade de Pointes (TdP), or uncontrolled electrolyte disorders * Child-bearing potential women not using highly effective methods of contraception. * Known hypersensitivity to eribulin, endocrine therapy or its excipients. * Other malignancies within the previous two years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix or breast. * Known uncontrolled metastases to the central nervous system (CNS) or any progressing CNS disease. * Have a serious concomitant systemic disorder incompatible with the study. * Major surgical procedure or significant traumatic injury within 28 days prior to randomization. * Have received any anti-cancer biology or investigational treatment within 30 days prior to randomization.
References
Publications (0)
Data not yet available
No reference posted for this study.