Breast Diseases, Breast Neoplasms, Neoplasms, Neoplasms by Site, Skin Diseases
Conditions
Keywords
Trabectedin, Yondelis, ET743, Advanced breast cancer, Breast, Cancer, Antineoplastic Agents, Alkylating Agents, Molecular Mechanisms of Pharmacological Action
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.
Interventions
DRUGET743
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.
Sponsors
PharmaMar
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with objective response in each treatment arm. | Up to approximately 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed