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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077857

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: capecitabine [Xeloda] Drug: Taxotere	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Capecitabine

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	701
Study Start Date:	July 2003
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1250mg/m2 iv on days 1-14 of each 3 week cycle. Drug: Taxotere 75mg/m2 iv on day 1 of each 3 week cycle
2: Experimental	Drug: capecitabine [Xeloda] 825mg/m2 iv on days 1-14 of each 3 week cycle. Drug: Taxotere 75mg/m2 iv on day 1 of each 3 week cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077857

Show 94 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NO16853
Study First Received:	February 12, 2004
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00077857 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Docetaxel
Capecitabine
Skin Diseases

Disease Progression
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms

Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on September 03, 2009