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

NCT ID: NCT01777945

Last Updated: 2016-08-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants Receiving Capecitabine/Docetaxel

Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.

capecitabine

Intervention Type DRUG

Participants received capecitabine according to individualized physician-prescribed regimen.

docetaxel

Intervention Type DRUG

Participants received docetaxel according to individualized physician-prescribed regimens.

Interventions

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capecitabine

Participants received capecitabine according to individualized physician-prescribed regimen.

Intervention Type DRUG

docetaxel

Participants received docetaxel according to individualized physician-prescribed regimens.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Gyula, , Hungary

Site Status

Kaposvár, , Hungary

Site Status

Kecskemét, , Hungary

Site Status

Miskolc, , Hungary

Site Status

Nyíregyháza, , Hungary

Site Status

Szeged, , Hungary

Site Status

Szombathely, , Hungary

Site Status

Veszprém, , Hungary

Site Status

Zalaegerszeg, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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ML28505

Identifier Type: -

Identifier Source: org_study_id

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