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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01725386
First received: November 8, 2012
Last updated: June 30, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Breast Cancer
Drug: Capecitabine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Receiving Capecitabine Monotherapy Versus Combination Therapy [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Receiving Concomitant Medications During the Study [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
    To document use of Capecitabine regimen with concomitant medication use in the management of participants with metastatic breast cancer, the percentage of participants receiving concomitant medications during the study was summarized.


Secondary Outcome Measures:
  • Percentage of Participants With Relevant Medical History Assessed at Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.

  • Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • Mean Survival Time [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 274
Study Start Date: March 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Monotherapy
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
Drug: Capecitabine
Oral tablet(s) administered according to prescribing information
Other Name: 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 Name: XELODA

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with metastatic breast cancer initiated on therapy with capecitabine
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725386

Locations
Pakistan
Abbottabad, Pakistan
Faisalabad, Pakistan
Gujranwala, Pakistan
Hyderabad, Pakistan
Islamabad, Pakistan, 44000
Islamabad, Pakistan
Karachi, Pakistan, 74700
Karachi, Pakistan, 75500
Karachi, Pakistan
Lahore, Pakistan, 54600
Lahore, Pakistan
Multan, Pakistan
Peshwar, Pakistan
Rawalpindi, Pakistan, 46000
Rawalpindi, Pakistan
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01725386     History of Changes
Other Study ID Numbers: ML25640 
Study First Received: November 8, 2012
Results First Received: June 30, 2016
Last Updated: June 30, 2016
Health Authority: Pakistan: Drug Regulatory Authority of Pakistan

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 25, 2016