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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Xeloda dosage/schedule in routine clinical practice

Outcome Time Frame:

approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Pakistan: Ministry of Health

Study ID:

ML25640

NCT ID:

NCT01725386

Start Date:

March 2011

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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