Clinical trial NCT00050427: A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer
Official title: A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Keywords: Trabectedin
Yondelis
ET743
Advanced breast cancer
Breast
Cancer
Antineoplastic Agents, Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PharmaMar
First posted: 2002-12-18
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Patients will be enrolled in the study after all study specific-entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin 580 mcg/m2 once weekly for 3 consecutive weeks (Treatment A) or 1,300 mcg/m2 once every 21 days (Treatment B) will be given to patients as a 3-hour intravenous (i.v). infusion via a central venous catheter which is a tube placed into a large vein that is used to administer medications. All patients will be given dexamethasone 10 mg i.v. 30 minutes before each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with objective response in each treatment arm.
timeFrame: Up to approximately 52 weeks
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 52 weeks
measure: Time to progression (TTP)
timeFrame: Up to approximately 52 weeks
measure: Overall survival (OS)
timeFrame: Up to approximately 52 weeks
measure: The number of patients with treatment-emergent adverse events
timeFrame: Up to approximately 52 weeks
measure: Concentrations of trabectedin in plasma as a measure of the pharmacokinetics of trabectedin
timeFrame: During the first two 28-day treatment cycles
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.