Clinical trial · Interventional
A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer
A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer
NCT00050427CI-TRIAL-00004745completedPhase 2ClinicalTrials.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 this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer.
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 |
|---|---|---|---|
| Breast Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Skin Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ET743 | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 001
- description
- ET743 580 mcg/m2 3-hour i.v. infusion on Days 1 8 and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.
- interventionNames
- Drug: ET743
- type
- EXPERIMENTAL
- label
- 002
- description
- ET743 1 300 mcg/m2 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.
- interventionNames
- Drug: ET743
Primary outcomes (1)
- measure
- Number of patients with objective response in each treatment arm.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of advanced breast cancer * Prior therapy with anthracycline and taxane (2 types of chemotherapy drugs) * At least one measureable tumor lesion * Adequate bone marrow, hepatic and renal function * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: * Known hypersensitivity to any components of the i.v. formulation of ET-743 or dexamethasone * Pregnant or lactating women * Known metastases (spread) of cancer to the central nervous system * History of another neoplastic disease unless in remission for five years or more.
References
Publications (1)
- DERIVEDGoldstein LJ, Gurtler J, Del Prete SA, Tjulandin S, Semiglazov VF, Bayever E, Michiels B. Trabectedin as a single-agent treatment of advanced breast cancer after anthracycline and taxane treatment: a multicenter, randomized, phase II study comparing 2 administration regimens. Clin Breast Cancer. 2014 Dec;14(6):396-404. doi: 10.1016/j.clbc.2014.06.006. Epub 2014 Aug 15. PMID 25239225