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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01777945

Enrollment

Registered

2013-01-29

Start date

2012-12-31

Completion date

2014-12-31

Last updated

2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGcapecitabine

Participants received capecitabine according to individualized physician-prescribed regimen.

DRUGdocetaxel

Participants received docetaxel according to individualized physician-prescribed regimens.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Time to Treatment Failure	approximately 2 years	The time from enrollment to discontinuation of any drug of the treatment combination.
Percentage of Capecitabine Dose Modifications	approximately 2 years	—
Number of Participants With Adverse Events	approximately 2 years	—
Duration of Treatment With Xeloda	approximately 2 years	—

Countries

Hungary

Participant flow

Pre-assignment details

46 participants were enrolled in the study and included in safety assessments. 45 participants were included in other assessments.

Participants by arm

Arm	Count
Participants Receiving Capecitabine/Docetaxel Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.	45
Total	45

Baseline characteristics

Characteristic	Participants Receiving Capecitabine/Docetaxel
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	15 Participants
Age, Categorical Between 18 and 65 years	30 Participants
Age, Continuous	58.58 years STANDARD_DEVIATION 11.359
Region of Enrollment Hungary	45 participants
Sex: Female, Male Female	45 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	21 / 46
serious Total, serious adverse events	8 / 46

Outcome results

Primary

Progression-free Survival (PFS)

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.