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

Completed

• Conditions: Breast Cancer
• Interventions: Drug: capecitabine; Drug: docetaxel

• Registration Number: NCT01777945
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-02
• Results First Submitted: 2016-04-12
• Results First Submitted QC: 2016-07-12
• Last Update Submitted: 2016-07-12
• Results First Posted: 2016-08-19
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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Exclusion Criteria

• Contraindications to Xeloda treatment according to the Summary of Product Characteristics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants Receiving Capecitabine/Docetaxel	capecitabine	Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Participants Receiving Capecitabine/Docetaxel	docetaxel	Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	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

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