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

Tracking Information

First Received Date ^ICMJE

February 12, 2004

Last Updated Date

October 15, 2009

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time to disease progression or death [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Time to disease progression or death due to any cause

Change History

Complete list of historical versions of study NCT00077857 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall response, time to response, duration of overall response, time to treatment failure, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs, premature withdrawals, planned vs received dose. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: Overall response, time to response, duration of overall response, time to treatment failure, overall survival
Safety: AEs, lab tests, premature withdrawals, vital signs, planned vs received dose

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

This 2 arm study will compare the efficacy and safety of label dose Xeloda to that of a lower dose of Xeloda plus Taxotere in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline.Patients will be randomized to receive either 1250mg/m2 or 825mg/m2 po bid on days 1-14 of each 3 week cycle, in combination with Taxotere 75mg/m2 iv on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression and the target sample size is 100-500 individuals.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: capecitabine [Xeloda]
Drug: Taxotere

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

440

Estimated Completion Date

January 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Bosnia and Herzegovina, China, Czech Republic, India, Poland, Russian Federation, South Africa, Thailand

Administrative Information

NCT ID ^ICMJE

NCT00077857

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study ID Numbers ^ICMJE

NO16853

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP