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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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