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Completed

NCT Number: NCT01777945

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

Participants received capecitabine according to individualized physician-prescribed regimen.

docetaxel

Drug

Participants received docetaxel according to individualized physician-prescribed regimens.

Primary outcomes

  1. 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 outcomes

  1. Time to Treatment Failure

    Time frame: approximately 2 years

    The time from enrollment to discontinuation of any drug of the treatment combination.

  2. 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.

  3. Clinical Benefit Rate

    Time frame: approximately 2 years

    The percentage of participants with an overall response (complete or partial remission) or with stable disease.

  4. Duration of Treatment With Xeloda

    Time frame: approximately 2 years

  5. Percentage of Capecitabine Dose Modifications

    Time frame: approximately 2 years

  6. Number of Participants With Adverse Events

    Time frame: approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2013
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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