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OpenTrials
Completed

NCT Number: NCT01725386

An Observational Study of Xeloda (Capecitabine) in Participants 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Abbottabad, Pakistan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

Oral tablet(s) administered according to prescribing information

Other names: XELODA

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Mean Survival Time

    Time frame: Up to approximately 4 years

  4. Percentage of Participants With Adverse Events

    Time frame: Up to approximately 4 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: XEPAD

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 12, 2012
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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