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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01777945
First received: January 25, 2013
Last updated: July 12, 2016
Last verified: February 2016
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The time from enrollment to discontinuation of any drug of the treatment combination.

  • Overall Response Rate [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of Capecitabine Dose Modifications [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 25, 2013
Results First Received: April 12, 2016
Last Updated: July 12, 2016
Health Authority: Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on December 09, 2016