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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725386
• Other study ID #: ML25640
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: May 4, 2016
• Start date: March 2011
• Est. completion date: February 2015

Study information

• Verified date: May 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult female patients, >/= 18 years of age

• Cytolologic/histopathologic confirmed diagnosis of metastatic breast cancer

• Prescribed Xeloda 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Xeloda dosage/schedule in routine clinical practice		approximately 4 years	No
Primary	Regimen/concomitant medication used in routine clinical practice		approximately 4 years	No
Secondary	Clinical/demographic patient characteristics at initiation of treatment		approximately 4 years	No
Secondary	Progression-free survival		approximately 4 years	No
Secondary	Safety: Incidence of adverse events		approximately 4 years	No