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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01725386
Recruitment Status : Completed
First Posted : November 12, 2012
Results First Posted : August 12, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Drug: Capecitabine

Study Design
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Study Type : Observational
Actual Enrollment : 274 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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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 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725386


Locations
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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
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01725386    
Other Study ID Numbers: ML25640
First Posted: November 12, 2012    Key Record Dates
Results First Posted: August 12, 2016
Last Update Posted: September 28, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents