A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Dec 17, 2002

Keywords

ClinConnect Summary

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 ...

Gender

FEMALE

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.