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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Treatments: Antineoplastic Agents, Alkylating; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Molecular Mechanisms of Pharmacological Action; Trabectedin

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.