Clinical trial · Interventional
PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment
Multicenter, Interventional, Single-arm, Phase IV Study Evaluating Tolerability of Eribulin and Its Relationship With a Set of Polymorphisms in an Unselected Population of Female Patients With Metastatic Breast Cancer
- 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)
On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease. As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted. Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Drug Event | — | UNRESOLVED | — |
| Drug Toxicity | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Neurotoxicity | — | UNRESOLVED | — |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERIBULIN MESYLATE | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm with Eribulin mesylate
- interventionNames
- Drug: ERIBULIN MESYLATE
Primary outcomes (5)
- measure
- Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade)
- timeFrame
- Trough study completion, an average of 1 year
- description
- All toxicities and their grade will be reported according to Common Terminology criteria for Adverse Events (CTCAE) v4.0, especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities.
- measure
- Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy
- timeFrame
- Trough study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of metastatic breast cancer * Previous treatment with anthracyclines and taxanes * Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication * Ability to comply with sample collection * Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF. * Absence of any contraindication to treatment Exclusion Criteria: * Previous treatment with Eribulin in a previous line of treatment * Previous treatment with Eribulin off label
References
Publications (22)
- BACKGROUNDGuarneri V, Conte PF. The curability of breast cancer and the treatment of advanced disease. Eur J Nucl Med Mol Imaging. 2004 Jun;31 Suppl 1:S149-61. doi: 10.1007/s00259-004-1538-5. Epub 2004 Apr 24. PMID 15107948
- BACKGROUNDMauri D, Polyzos NP, Salanti G, Pavlidis N, Ioannidis JP. Multiple-treatments meta-analysis of chemotherapy and targeted therapies in advanced breast cancer. J Natl Cancer Inst. 2008 Dec 17;100(24):1780-91. doi: 10.1093/jnci/djn414. Epub 2008 Dec 9. PMID 19066278
- BACKGROUNDKobayashi T, Ichiba T, Sakuyama T, Arakawa Y, Nagasaki E, Aiba K, Nogi H, Kawase K, Takeyama H, Toriumi Y, Uchida K, Kobayashi M, Kanehira C, Suzuki M, Ando N, Natori K, Kuraishi Y. Possible clinical cure of metastatic breast cancer: lessons from our 30-year experience with oligometastatic breast cancer patients and literature review. Breast Cancer. 2012 Jul;19(3):218-37. doi: 10.1007/s12282-012-0347-0. Epub 2012 Apr 25. PMID 22532161
- BACKGROUNDJordan 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. PMID 16020666
- BACKGROUNDOkouneva T, Azarenko O, Wilson L, Littlefield BA, Jordan MA. Inhibition of centromere dynamics by eribulin (E7389) during mitotic metaphase. Mol Cancer Ther. 2008 Jul;7(7):2003-11. doi: 10.1158/1535-7163.MCT-08-0095. PMID 18645010
- BACKGROUNDTowle MJ, Salvato KA, Budrow J, Wels BF, Kuznetsov G, Aalfs KK, Welsh S, Zheng W, Seletsky BM, Palme MH, Habgood GJ, Singer LA, Dipietro LV, Wang Y, Chen JJ, Quincy DA, Davis A, Yoshimatsu K, Kishi Y, Yu MJ, Littlefield BA. In vitro and in vivo anticancer activities of synthetic macrocyclic ketone analogues of halichondrin B. Cancer Res. 2001 Feb 1;61(3):1013-21. PMID 11221827