XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
NCT ID: NCT00127933
Last Updated: 2011-08-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
157 participants
INTERVENTIONAL
2005-08-31
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
NCT00089479
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
NCT01301729
Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer
NCT01662128
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
NCT02748213
Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery
NCT00251329
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HER2-NEU Positive
capecitabine [Xeloda]
825mg/m2 po bid on days 1-14 of each 3 week cycle
Taxotere
75mg/m2 iv on day 1 of each 3 week cycle
Herceptin (HER2-neu positive patients only)
4mg/kg iv (loading dose) followed by 2mg/kg iv weekly
HER2-NEU Negative
capecitabine [Xeloda]
825mg/m2 po bid on days 1-14 of each 3 week cycle
Taxotere
75mg/m2 iv on day 1 of each 3 week cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
capecitabine [Xeloda]
825mg/m2 po bid on days 1-14 of each 3 week cycle
Taxotere
75mg/m2 iv on day 1 of each 3 week cycle
Herceptin (HER2-neu positive patients only)
4mg/kg iv (loading dose) followed by 2mg/kg iv weekly
capecitabine [Xeloda]
825mg/m2 po bid on days 1-14 of each 3 week cycle
Taxotere
75mg/m2 iv on day 1 of each 3 week cycle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* newly diagnosed;
* infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.
Exclusion Criteria
* previous systemic or local primary treatment.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hoffmann-La Roche
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles, California, United States
Montebello, California, United States
Palm Springs, California, United States
San Diego, California, United States
Farmington, Connecticut, United States
Melbourne, Florida, United States
Miami, Florida, United States
Tamarac, Florida, United States
Savannah, Georgia, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Alexandria, Louisiana, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Edina, Minnesota, United States
Jefferson City, Missouri, United States
Rolla, Missouri, United States
St Louis, Missouri, United States
Neptune City, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
New York, New York, United States
Charlotte, North Carolina, United States
Canton, Ohio, United States
Pittsburgh, Pennsylvania, United States
Pottsville, Pennsylvania, United States
Charleston, South Carolina, United States
Georgetown, South Carolina, United States
Sumter, South Carolina, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Burlington, Vermont, United States
Abingdon, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML18530
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.