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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777945
• Other study ID #: ML28505
• Status: Completed
• Phase: N/A
• First received: January 25, 2013
• Last updated: February 1, 2016
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival, defined as time from enrollment until disease progression or death of any cause		approximately 3 years	No
Secondary	Time to treatment failure, defined as time from enrollment to discontinuation of any drug of the treatment combination		approximately 3 years	No
Secondary	Overall response rate		approximately 3 years	No
Secondary	Clinical benefit rate		approximately 3 years	No
Secondary	Duration of treatment with Xeloda		approximately 3 years	No
Secondary	Rate of Xeloda dose modifications		approximately 3 years	No
Secondary	Safety: Incidence of adverse events		approximately 3 years	No