An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer (XEPAD)

August 19, 2016 updated by: Hoffmann-La Roche

Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer

This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible participants will be followed for up to 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Abbottabad, Pakistan
      • Faisalabad, Pakistan
      • Gujranwala, Pakistan
      • Hyderabad, Pakistan
      • Islamabad, Pakistan
      • Islamabad, Pakistan, 44000
      • Karachi, Pakistan
      • Karachi, Pakistan, 75500
      • Karachi, Pakistan, 74700
      • Lahore, Pakistan
      • Lahore, Pakistan, 54600
      • Multan, Pakistan
      • Peshwar, Pakistan
      • Rawalpindi, Pakistan
      • Rawalpindi, Pakistan, 46000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Participants with metastatic breast cancer initiated on therapy with capecitabine

Description

Inclusion Criteria:

  • Adult female participants, >/= 18 years of age
  • Cytologic/histopathologic confirmed diagnosis of metastatic breast cancer
  • Prescribed capecitabine as in routine clinical practice
  • Informed consent signed

Exclusion Criteria:

  • Participation in any other clinical trial
  • History of severe and unexpected reactions to fluoropyrimidine therapy
  • Hypersensitivity to capecitabine or to any of the excipients of fluorouracil
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Pregnant or lactating women
  • Severe leucopenia, neutropenia, or thrombocytopenia
  • Severe hepatic impairment
  • Severe renal impairment (creatinine clearance below 30 ml/min)
  • Treatment with sorivudine or its chemically related analogues, such as brivudine
  • Refusal to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Monotherapy
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
Drug: Capecitabine
Oral tablet(s) administered according to prescribing information
Other Names:
  • XELODA
Combination Therapy
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
Drug: Capecitabine
Oral tablet(s) administered according to prescribing information
Other Names:
  • XELODA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
Time Frame: Up to approximately 4 years
To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.
Up to approximately 4 years
Percentage of Participants Receiving Concomitant Medications During the Study
Time Frame: Up to approximately 4 years
Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Relevant Medical History Assessed at Baseline
Time Frame: Day 1
To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.
Day 1
Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
Time Frame: Day 1
To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.
Day 1
Mean Survival Time
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Percentage of Participants With Adverse Events
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

November 8, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (ESTIMATE)

November 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25640

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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