An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body until it kills) participants.

Key facts

Study ID

NCT00580112

Run by

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

People needed

127

Starts

2007-06-01

Expected to finish

2011-08-01

Last updated by the study team

2014-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with histologically proven diagnosis of progressive metastatic breast cancer
• Participants with measurable disease as per the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
• Participants with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present
• Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 and adequately recovered from the acute toxicity of any prior treatment
• Participants with serum creatinine less than or equal to 1.5 milligram per deciliter (mg/dl) or creatinine clearance greater than or equal to 30 milliliter per minute (ml/min)

You may not qualify if…

• Participants with previous exposure to trabectedin
• Participants with more than 3 previous chemotherapy regimens for metastatic disease and known hypersensitivity to components of trabectedin intravenous formulation or dexamethasone
• Pregnant or lactating women or any women of childbearing potential who is not employing adequate contraception
• Completion of previous therapy : Less than 2 weeks from radiation therapy or last dose of hormonal therapy, less than 3 weeks from previous biological therapy or chemotherapy
• Participants with known leptomeningeal disease and other serious illnesses like congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias or active infection or psychiatric disorder or active viral hepatitis

Where it is running

• Study site — Sedona, Arizona, United States
• Study site — Denver, Colorado, United States
• Study site — Torrington, Connecticut, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Westminster, Maryland, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Columbia, Missouri, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Amsterdam, New York, United States
• Study site — New York, New York, United States
• Study site — Bedford, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Salem, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Spokane, Washington, United States
• Study site — Yakima, Washington, United States
• Study site — Bourdeaux, France
• Study site — Marseille, France
• Study site — Saint-Herblain, France
• Study site — Strasbourg, France

Full record on ClinicalTrials.gov

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