To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older

Stopped early · Phase 3

Conditions studied: Metastatic Breast Cancer

In brief

The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.

Key facts

Study ID

NCT00082095

Run by

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

People needed

62

Starts

2004-04-01

Expected to finish

2005-12-01

Last updated by the study team

2014-10-09

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Clinically or pathologically proven metastatic breast cancer
• Eastern Cooperative Oncology Group performance status between 0-2
• Adequate bone marrow, renal and liver functions within normal limits
• Left ventricular ejection fractions more than 45% measured by multiple gated acquisition scan or echocardiogram within 6 weeks of randomization

You may not qualify if…

• Prior chemotherapy for metastatic disease (hormonal or chemotherapy in adjuvant setting and hormonal therapy in metastatic setting is allowed)
• Prior treatment with capecitabine or pegylated liposomal doxorubicin in the adjuvant setting (prior anthracyclines up to certain dose limit is allowed)
• Evidence of brain metastases unless previously treated and asymptomatic for 3 months or greater
• History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
• Anthracycline resistant disease (locally recurrent or metastatic disease while on adjuvant anthracycline therapy or relapse less than 18 months after therapy completion)

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — Oxnard, California, United States
• Study site — Soquel, California, United States
• Study site — Boca Raton, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Springfield, Illinois, United States
• Study site — Hazard, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Scarborough, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Clinton Township, Michigan, United States
• Study site — Saint Louis Park, Minnesota, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Armonk, New York, United States
• Study site — New City, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Fort Worth, Texas, United States
• Study site — Fredericksburg, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Colchester, Vermont, United States

Full record on ClinicalTrials.gov

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