Eribulin in Brain Metastases From HER2-negative Breast Cancer
NCT ID: NCT03637868
Last Updated: 2020-05-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2019-02-26
Study Completion Date
2020-04-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To evaluate the efficacy of eribulin for treatment of HER2-negative breast cancer brain metastases (BCBM)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory
NCT01240421
Metastatic Breast Cancer
APPROVED_FOR_MARKETING
Eribulin in HER2 Negative Metastatic BrCa
NCT01827787
Breast Cancer
COMPLETED
PHASE2
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
NCT01268150
Locally Recurrent
Metastatic Breast Cancer ( HER2 Negative)
COMPLETED
PHASE2
Extended Treatment in Metastatic Breast Cancer With Eribulin
NCT02769364
Breast Cancer
COMPLETED
Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment
NCT02061085
Breast Neoplasm
Metastasis
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will explore eribulin in three specific cohorts of patients with HER2-negative metastatic breast cancer harboring BCBM, pretreated with anthracyclines and taxanes:
* Cohort A = Newly diagnosed, untreated BCBM, not candidate to initial surgery or stereotactic radiosurgery (SRS) and with pauci-symptomatic disease not requiring immediate whole-brain radiation therapy (WBRT)
* Cohort B = BCBM pretreated with SRS and/or surgery alone, without WBRT, and not requiring immediate WBRT
* Cohort C = BCBM pretreated with WBRT
* Cohort A = Newly diagnosed, untreated BCBM, not candidate to initial surgery or stereotactic radiosurgery (SRS) and with pauci-symptomatic disease not requiring immediate whole-brain radiation therapy (WBRT)
* Cohort B = BCBM pretreated with SRS and/or surgery alone, without WBRT, and not requiring immediate WBRT
* Cohort C = BCBM pretreated with WBRT
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Metastatic Breast Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Prospective, national, multicenter, open-label, uncontrolled, multi-cohort phase II trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Eribulin
eribulin 1.4 mg/m² administered intravenously between 6 and 7 cycles.
Group Type
EXPERIMENTAL
Eribulin
Intervention Type
DRUG
Patients will receive eribulin 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eribulin
Patients will receive eribulin 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. At least 18 years of age.
2. Life expectancy of 3 months or longer.
3. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2.
4. HER2-negative (IHC 0/1+ or 2+ and in situ hybridization negative) metastatic breast cancer
5. Locally advanced or metastatic breast cancer that have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. (no limit to the number of previous lines of therapy, no need for extracranial disease)
6. At least 2 weeks washout period post chemotherapy, targeted or biologic therapy, or radiation therapy is required prior to study entry
7. Patient with untreated CNS disease or previous SRS/surgery without WBRT (cohorts A and B)
* At least 1 measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI, OR
* At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm.
8. Patient with progressive disease harboring brain metastases after previous WBRT (cohort C)
* At least 1 measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI, OR
* At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm.
9. Adequate organ function as evidenced by:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L without granulocyte-colony-stimulating factor G-CSF (filgrastim, pegfilgrastim, or equivalent) support within 7 days
* Hemoglobin (Hgb) ≥ 9.0 g/dL (90 g/L) without blood transfusion within 7 days
* Platelet count ≥ 100 x 10e9/L without platelet transfusion within 7 days
* Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with documented history of Gilbert's disease who may have DIRECT bilirubin ≤ 1.5 X ULN
* Alanine aminotransferase (ALT) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases
* Aspartate aminotransferase (AST) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases
* Serum creatinine ≤ 1.5 X ULN; or calculated creatinine clearance ≥ 50 mL/min (using MDRD formula), or measured creatinine clearance ≥ 50 mL/min
2. Life expectancy of 3 months or longer.
3. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2.
4. HER2-negative (IHC 0/1+ or 2+ and in situ hybridization negative) metastatic breast cancer
5. Locally advanced or metastatic breast cancer that have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. (no limit to the number of previous lines of therapy, no need for extracranial disease)
6. At least 2 weeks washout period post chemotherapy, targeted or biologic therapy, or radiation therapy is required prior to study entry
7. Patient with untreated CNS disease or previous SRS/surgery without WBRT (cohorts A and B)
* At least 1 measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI, OR
* At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm.
8. Patient with progressive disease harboring brain metastases after previous WBRT (cohort C)
* At least 1 measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI, OR
* At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm.
9. Adequate organ function as evidenced by:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L without granulocyte-colony-stimulating factor G-CSF (filgrastim, pegfilgrastim, or equivalent) support within 7 days
* Hemoglobin (Hgb) ≥ 9.0 g/dL (90 g/L) without blood transfusion within 7 days
* Platelet count ≥ 100 x 10e9/L without platelet transfusion within 7 days
* Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with documented history of Gilbert's disease who may have DIRECT bilirubin ≤ 1.5 X ULN
* Alanine aminotransferase (ALT) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases
* Aspartate aminotransferase (AST) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases
* Serum creatinine ≤ 1.5 X ULN; or calculated creatinine clearance ≥ 50 mL/min (using MDRD formula), or measured creatinine clearance ≥ 50 mL/min
Exclusion Criteria
1. Prior therapy with eribulin.
2. Patients should not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. (Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period)
3. Patients may not have the following co morbid disease or concurrent illness:
* Known cirrhosis, defined as Child Pugh class A or higher liver disease
* Other active malignancy, except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder)
* Any other severe/uncontrolled inter current illness or significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation
* Patients with the presence of an active infection, abscess or fistula
* Known leptomeningeal disease or CNS midline shifts.
* Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease.
* Severe conduction abnormality including significant corrected QT interval QTc prolongation \>450ms.
* Patients with grade 3/4 peripheral neuropathy.
4. Patient candidate to SRS and or surgical resection
5. Major clinical symptoms requiring immediate WBRT as defined by "local tumor board"
6. Increase in corticosteroid dose in the week prior to baseline brain MRI
7. Patients with pacemaker or implantable cardioverter-defibrillator devices incompatible with MRI assessment.
8. Contraindication to Gadolinium infusion.
9. Treatment ongoing with other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except bisphosphonates or denosumab.
10. Pregnant or breast-feeding patients
11. Women of child-bearing potential without effective contraception method.
12. Patient unable to express their consent.
2. Patients should not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. (Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period)
3. Patients may not have the following co morbid disease or concurrent illness:
* Known cirrhosis, defined as Child Pugh class A or higher liver disease
* Other active malignancy, except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder)
* Any other severe/uncontrolled inter current illness or significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation
* Patients with the presence of an active infection, abscess or fistula
* Known leptomeningeal disease or CNS midline shifts.
* Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease.
* Severe conduction abnormality including significant corrected QT interval QTc prolongation \>450ms.
* Patients with grade 3/4 peripheral neuropathy.
4. Patient candidate to SRS and or surgical resection
5. Major clinical symptoms requiring immediate WBRT as defined by "local tumor board"
6. Increase in corticosteroid dose in the week prior to baseline brain MRI
7. Patients with pacemaker or implantable cardioverter-defibrillator devices incompatible with MRI assessment.
8. Contraindication to Gadolinium infusion.
9. Treatment ongoing with other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except bisphosphonates or denosumab.
10. Pregnant or breast-feeding patients
11. Women of child-bearing potential without effective contraception method.
12. Patient unable to express their consent.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai Inc.
INDUSTRY
Sponsor Role
collaborator
Institut Paoli-Calmettes
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Renaud Sabatier, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut de Cancerologie de L'Ouest - Paul Papin
Angers, , France
Site Status
Institut Sainte Catherine
Avignon, , France
Site Status
CHU Besançon
Besançon, , France
Site Status
Institut Paoli-Calmettes
Marseille, , France
Site Status
Institut Du Cancer de Montpellier
Montpellier, , France
Site Status
Institut De Cancérologie de l'Ouest
Saint-Herblain, , France
Site Status
Institut de Cancerologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Site Status
Countries
Review the countries where the study has at least one active or historical site.
France
References
Explore related publications, articles, or registry entries linked to this study.
Arslan C, Dizdar O, Altundag K. Chemotherapy and biological treatment options in breast cancer patients with brain metastasis: an update. Expert Opin Pharmacother. 2014 Aug;15(12):1643-58. doi: 10.1517/14656566.2014.929664.
Reference Type
BACKGROUND
Bart J, Nagengast WB, Coppes RP, Wegman TD, van der Graaf WT, Groen HJ, Vaalburg W, de Vries EG, Hendrikse NH. Irradiation of rat brain reduces P-glycoprotein expression and function. Br J Cancer. 2007 Aug 6;97(3):322-6. doi: 10.1038/sj.bjc.6603864. Epub 2007 Jul 3.
Reference Type
BACKGROUND
Bartsch R, Fromm S, Rudas M, Wenzel C, Harbauer S, Roessler K, Kitz K, Steger GG, Weitmann HD, Poetter R, Zielinski CC, Dieckmann K. Intensified local treatment and systemic therapy significantly increase survival in patients with brain metastases from advanced breast cancer - a retrospective analysis. Radiother Oncol. 2006 Sep;80(3):313-7. doi: 10.1016/j.radonc.2006.08.001. Epub 2006 Sep 7.
Reference Type
BACKGROUND
Chang AY, Ying XX. Brain Metastases from Breast Cancer and Response to Treatment with Eribulin: A Case Series. Breast Cancer (Auckl). 2015 May 24;9:19-24. doi: 10.4137/BCBCR.S21176. eCollection 2015.
Reference Type
BACKGROUND
Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.
Reference Type
BACKGROUND
Jimeno A. Eribulin: rediscovering tubulin as an anticancer target. Clin Cancer Res. 2009 Jun 15;15(12):3903-5. doi: 10.1158/1078-0432.CCR-09-1023. Epub 2009 Jun 9.
Reference Type
BACKGROUND
Joly F, Lange M, Rigal O, Correia H, Giffard B, Beaumont JL, Clisant S, Wagner L. French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3. Support Care Cancer. 2012 Dec;20(12):3297-305. doi: 10.1007/s00520-012-1439-2. Epub 2012 May 2.
Reference Type
BACKGROUND
Jordan MA, Kamath K, Manna T, Okouneva T, Miller HP, Davis C, Littlefield BA, Wilson L. The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther. 2005 Jul;4(7):1086-95. doi: 10.1158/1535-7163.MCT-04-0345.
Reference Type
BACKGROUND
Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.
Reference Type
BACKGROUND
Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.
Reference Type
BACKGROUND
Lu J, Steeg PS, Price JE, Krishnamurthy S, Mani SA, Reuben J, Cristofanilli M, Dontu G, Bidaut L, Valero V, Hortobagyi GN, Yu D. Breast cancer metastasis: challenges and opportunities. Cancer Res. 2009 Jun 15;69(12):4951-3. doi: 10.1158/0008-5472.CAN-09-0099. Epub 2009 May 26. No abstract available.
Reference Type
BACKGROUND
Matsuoka H, Tsurutani J, Tanizaki J, Iwasa T, Komoike Y, Koyama A, Nakagawa K. Regression of brain metastases from breast cancer with eribulin: a case report. BMC Res Notes. 2013 Dec 18;6:541. doi: 10.1186/1756-0500-6-541.
Reference Type
BACKGROUND
Narayan S, Carlson EM, Cheng H, Condon K, Du H, Eckley S, Hu Y, Jiang Y, Kumar V, Lewis BM, Saxton P, Schuck E, Seletsky BM, Tendyke K, Zhang H, Zheng W, Littlefield BA, Towle MJ, Yu MJ. Novel second generation analogs of eribulin. Part III: Blood-brain barrier permeability and in vivo activity in a brain tumor model. Bioorg Med Chem Lett. 2011 Mar 15;21(6):1639-43. doi: 10.1016/j.bmcl.2011.01.096. Epub 2011 Jan 26.
Reference Type
BACKGROUND
Pivot X, Marme F, Koenigsberg R, Guo M, Berrak E, Wolfer A. Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy. Ann Oncol. 2016 Aug;27(8):1525-31. doi: 10.1093/annonc/mdw203. Epub 2016 May 13.
Reference Type
BACKGROUND
Qin DX, Zheng R, Tang J, Li JX, Hu YH. Influence of radiation on the blood-brain barrier and optimum time of chemotherapy. Int J Radiat Oncol Biol Phys. 1990 Dec;19(6):1507-10. doi: 10.1016/0360-3016(90)90364-p.
Reference Type
BACKGROUND
Schwartz LH, Litiere S, de Vries E, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, Seymour L. RECIST 1.1-Update and clarification: From the RECIST committee. Eur J Cancer. 2016 Jul;62:132-7. doi: 10.1016/j.ejca.2016.03.081. Epub 2016 May 14.
Reference Type
BACKGROUND
Thavarajah N, Bedard G, Zhang L, Cella D, Beaumont JL, Tsao M, Barnes E, Danjoux C, Sahgal A, Soliman H, Chow E. Psychometric validation of the functional assessment of cancer therapy--brain (FACT-Br) for assessing quality of life in patients with brain metastases. Support Care Cancer. 2014 Apr;22(4):1017-28. doi: 10.1007/s00520-013-2060-8. Epub 2013 Nov 28.
Reference Type
BACKGROUND
Toth K, Vaughan MM, Peress NS, Slocum HK, Rustum YM. MDR1 P-glycoprotein is expressed by endothelial cells of newly formed capillaries in human gliomas but is not expressed in the neovasculature of other primary tumors. Am J Pathol. 1996 Sep;149(3):853-8.
Reference Type
BACKGROUND
Zhang RD, Price JE, Fujimaki T, Bucana CD, Fidler IJ. Differential permeability of the blood-brain barrier in experimental brain metastases produced by human neoplasms implanted into nude mice. Am J Pathol. 1992 Nov;141(5):1115-24.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-001027-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ERIBRAIN-IPC 2017-014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Pilot Study of Eribulin in Breast Cancer (BC) Patients With Brain Metastases Previously Treated With Anthracyclines and Taxanes
NCT03412955
UNKNOWN
PHASE2
Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer
NCT05302778
UNKNOWN
Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies
NCT01142661
COMPLETED
NA
Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
NCT01269346
COMPLETED
PHASE2
Retroprospective Real Life Observatory of Eribulin
NCT02393287
COMPLETED
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients
NCT03795012
TERMINATED
PHASE2
A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer
NCT03583944
COMPLETED
PHASE4
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
NCT03786094
TERMINATED
PHASE3
Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer
NCT02551263
COMPLETED
A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer
NCT02623972
ACTIVE_NOT_RECRUITING
PHASE2
A Study to Investigate the Efficacy and Safety of Eribulin in Korean Breast Cancer Participants
NCT03437083
COMPLETED
Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer
NCT01388647
TERMINATED
PHASE1/PHASE2
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Participants With Metastatic Triple-Negative Breast Cancer (mTNBC)
NCT02513472
COMPLETED
PHASE1/PHASE2
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
NCT01401959
COMPLETED
PHASE2
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
NCT01432886
COMPLETED
PHASE1
A Confirmation Study of Eribulin in Combination With Capecitabine
NCT01323530
COMPLETED
PHASE1/PHASE2
Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer
NCT02790320
COMPLETED
Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer
NCT05079360
WITHDRAWN
PHASE2
A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC
NCT05945368
UNKNOWN
PHASE2
Study of E7389 for Advanced or Metastatic Breast Cancer
NCT00965523
COMPLETED
PHASE2
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
NCT01463891
COMPLETED
Efficacy and Safety of Biweekly Regimen of Eribulin Versus a Standard Regimen for the Treatment of Locally Recurrent or Metastatic HER2-negative Breast Cancer: a Multicenter, Randomized, Open-label, Phase III Trial
NCT06857305
ENROLLING_BY_INVITATION
PHASE3
Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer
NCT01961544
COMPLETED
PHASE4
Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
NCT05402722
UNKNOWN
PHASE2
A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients
NCT01795586
COMPLETED
PHASE1