A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression of Disease or Death

Outcome Description:

Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.

Outcome Time Frame:

Event driven (after 350 events). Median observation time was approximately 16 months.

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO16853

NCT ID:

NCT00077857

Start Date:

July 2003

Completion Date:

March 2010

Related Keywords:

• Breast Cancer
• Breast Neoplasms