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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00077857

Public ClinicalTrials.gov record NCT00077857. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 3, 2026, 8:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00077857
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
470 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2003 (Type not available)
Primary completion
Mar 2010 (Actual)
Completion
Mar 2010 (Actual)
Last update posted
May 10, 2013

2003 – 2010

United States locations

U.S. sites
43
U.S. states
23
U.S. cities
42
Facility City State ZIP Site status
Not listed Birmingham Alabama 35233 —
Not listed Hoover Alabama 35216 —
Not listed Tucson Arizona 85715 —
Not listed Berkeley California 94704 —
Not listed Poway California 92064 —
Not listed Boca Raton Florida 33486 —
Not listed Fort Lauderdale Florida 33308 —
Not listed Inverness Florida 34452 —
Not listed Jacksonville Florida 32207 —
Not listed Miami Shores Florida 33179 —
Not listed Port Saint Lucie Florida 34952 —
Not listed Tamarac Florida 33321 —
Not listed Skokie Illinois 60076 —
Not listed Urbana Illinois 61801 —
Not listed Beech Grove Indiana 46107 —
Not listed Des Moines Iowa 50314 —
Not listed Overland Park Kansas 66210 —
Not listed Houma Louisiana 70360 —
Not listed Baltimore Maryland 21202 —
Not listed Baltimore Maryland 21236 —
Not listed Frederick Maryland 21701 —
Not listed Rockville Maryland 20850-3348 —
Not listed Boston Massachusetts 02118 —
Not listed Detroit Michigan 48202-2689 —
Not listed Kalamazoo Michigan 49007 —
Not listed Jefferson City Missouri 65109 —
Not listed Saint Joseph Missouri 64507 —
Not listed Paramus New Jersey 07652 —
Not listed Summit New Jersey 07901 —
Not listed Williamsville New York 14221 —
Not listed Canton Ohio 44718 —
Not listed Mayfield Heights Ohio 44124 —
Not listed Allentown Pennsylvania 18104 —
Not listed Kingston Pennsylvania 18704 —
Not listed Charleston South Carolina 29406 —
Not listed Columbia South Carolina 29203 —
Not listed Collierville Tennessee 38017 —
Not listed Knoxville Tennessee 37920 —
Not listed Austin Texas 78705 —
Not listed Houston Texas 77030 —
Not listed Colchester Vermont 05446 —
Not listed Abingdon Virginia 24211 —
Not listed Walla Walla Washington 99362 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00077857, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 10, 2013 · Synced Oct 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00077857 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →