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

July 12, 2016 updated by: Hoffmann-La Roche

Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1067
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Treatment Failure
Time Frame: approximately 2 years
The time from enrollment to discontinuation of any drug of the treatment combination.
approximately 2 years
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.
approximately 2 years
Clinical Benefit Rate
Time Frame: approximately 2 years
The percentage of participants with an overall response (complete or partial remission) or with stable disease.
approximately 2 years
Duration of Treatment With Xeloda
Time Frame: approximately 2 years
approximately 2 years
Percentage of Capecitabine Dose Modifications
Time Frame: approximately 2 years
approximately 2 years
Number of Participants With Adverse Events
Time Frame: approximately 2 years
approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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