Text Size

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

This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01777945
First received: January 25, 2013
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in patients with HER2-negative metastatic breast cancer. Patients will be followed for approximately 6 months of treatment.


Condition
Breast Cancer

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:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival, defined as time from enrollment until disease progression or death of any cause [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure, defined as time from enrollment to discontinuation of any drug of the treatment combination [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of treatment with Xeloda [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Rate of Xeloda dose modifications [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • HER2-negative metastatic breast cancer
  • Patients initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; patients 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777945

Contacts
Contact: Reference Study ID Number: ML28505 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Hungary
Recruiting
Budapest, Hungary, 1067
Recruiting
Budapest, Hungary, 1125
Recruiting
Budapest, Hungary, 1122
Recruiting
Budapest, Hungary, 1145
Recruiting
Gyula, Hungary, 5700
Recruiting
Kaposvár, Hungary, 7400
Recruiting
Kecskemet, Hungary, 6000
Recruiting
Miskolc, Hungary, 3501
Recruiting
Nyíregyháza, Hungary, 4400
Recruiting
Szeged, Hungary, 6701
Recruiting
Szombathely, Hungary, 9700
Recruiting
Veszprem, Hungary, 8200
Recruiting
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01777945     History of Changes
Other Study ID Numbers: ML28505
Study First Received: January 25, 2013
Last Updated: June 3, 2013
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
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013