A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\^2 or 825 mg/m\^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.

Key facts

Study ID

NCT00077857

Run by

Hoffmann-La Roche

People needed

470

Starts

2003-07-01

Expected to finish

2010-03-01

Last updated by the study team

2013-05-10

Who can join

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

You may qualify if…

• women >=18 years of age;
• >=1 target lesion;
• locally advanced or metastatic breast cancer;
• demonstrated resistance to anthracycline;
• >=2 regimens of chemotherapy for advanced/metastatic disease.

You may not qualify if…

• previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
• previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Berkeley, California, United States
• Study site — Poway, California, United States
• Study site — Boca Raton, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Inverness, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami Shores, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Skokie, Illinois, United States
• Study site — Urbana, Illinois, United States
• Study site — Beech Grove, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Overland Park, Kansas, United States
• Study site — Houma, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Frederick, Maryland, United States
• Study site — Rockville, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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