A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.

Key facts

Study ID

NCT00091442

Run by

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

People needed

751

Starts

2004-09-01

Expected to finish

2008-12-01

Last updated by the study team

2014-04-21

Who can join

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

You may qualify if…

• Females with locally advanced or metastatic breast cancer who received prior anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a 12-month disease-free interval since the end of their last cytotoxic therapy, were eligible for the study
• Participants who received prior hormonal therapy, or no more than 1 cytotoxic chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not permitted), or both for advanced disease
• Participants with normal cardiac function, as evidenced by a normal left ventricular ejection fraction

You may not qualify if…

• More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer
• Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that included alkylating agents or antimetabolite agents was acceptable)
• Less than 2 months since the last dose of trastuzumab
• Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week since the last dose of other hormonal therapy
• Radiation to areas of disease within 30 days before study enrollment
• History of New York Heart Association Class II or greater cardiac disease or other clinical evidence of congestive heart failure

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Springs, California, United States
• Study site — Newark, Delaware, United States
• Study site — Lakeland, Florida, United States
• Study site — Fort Gordon, Georgia, United States
• Study site — Centralia, Illinois, United States
• Study site — Joliet, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Lafayette, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Jackson, Mississippi, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Newark, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Cooperstown, New York, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Gastonia, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Upland, Pennsylvania, United States
• Study site — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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