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XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777945
First Posted: January 29, 2013
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment.

Condition Intervention
Breast Cancer Drug: capecitabine Drug: docetaxel

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: approximately 2 years ]
    The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.


Secondary Outcome Measures:
  • Time to Treatment Failure [ Time Frame: approximately 2 years ]
    The time from enrollment to discontinuation of any drug of the treatment combination.

  • Overall Response Rate [ Time Frame: approximately 2 years ]
    The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.

  • Clinical Benefit Rate [ Time Frame: approximately 2 years ]
    The percentage of participants with an overall response (complete or partial remission) or with stable disease.

  • Duration of Treatment With Xeloda [ Time Frame: approximately 2 years ]
  • Percentage of Capecitabine Dose Modifications [ Time Frame: approximately 2 years ]
  • Number of Participants With Adverse Events [ Time Frame: approximately 2 years ]

Enrollment: 46
Study Start Date: December 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants Receiving Capecitabine/Docetaxel
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Drug: capecitabine
Participants received capecitabine according to individualized physician-prescribed regimen.
Drug: docetaxel
Participants received docetaxel according to individualized physician-prescribed regimens.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel
Criteria

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • HER2-negative metastatic breast cancer
  • Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible

Exclusion Criteria:

  • Contraindications to Xeloda treatment according to the Summary of Product Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777945


Locations
Hungary
Budapest, Hungary, 1067
Budapest, Hungary, 1122
Budapest, Hungary, 1125
Budapest, Hungary, 1145
Debrecen, Hungary, 4032
Gyula, Hungary, 5700
Kaposvár, Hungary, 7400
Kecskemet, Hungary, 6000
Miskolc, Hungary, 3501
Nyíregyháza, Hungary, 4400
Szeged, Hungary, 6720
Szombathely, Hungary, 9700
Veszprem, Hungary, 8200
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01777945     History of Changes
Other Study ID Numbers: ML28505
First Submitted: January 25, 2013
First Posted: January 29, 2013
Results First Submitted: April 12, 2016
Results First Posted: August 19, 2016
Last Update Posted: August 19, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites