NCT00050427

Brief Summary

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2002

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2002

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2002

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

First QC Date

December 9, 2002

Last Update Submit

April 26, 2011

Conditions

Breast NeoplasmsNeoplasmsNeoplasms by SiteBreast DiseasesSkin Diseases

Keywords

TrabectedinYondelisET743Advanced breast cancerBreastCancerAntineoplastic Agents, Alkylating AgentsMolecular Mechanisms of Pharmacological Action

Outcome Measures

Primary Outcomes (1)

  • Number of patients with objective response in each treatment arm.

    Up to approximately 52 weeks

Secondary Outcomes (5)

  • Progression-free survival (PFS)

    Up to approximately 52 weeks

  • Time to progression (TTP)

    Up to approximately 52 weeks

  • Overall survival (OS)

    Up to approximately 52 weeks

  • The number of patients with treatment-emergent adverse events

    Up to approximately 52 weeks

  • Concentrations of trabectedin in plasma as a measure of the pharmacokinetics of trabectedin

    During the first two 28-day treatment cycles

Study Arms (2)

001

EXPERIMENTAL

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.

Drug: ET743

002

EXPERIMENTAL

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.

Drug: ET743

Interventions

ET743DRUG

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.

001

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Goldstein 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: 25239225DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsNeoplasms by SiteBreast DiseasesSkin Diseases

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 9, 2002

First Posted

December 18, 2002

Study Start

December 1, 2002

Study Completion

December 1, 2006

Last Updated

April 28, 2011

Record last verified: 2011-04