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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 8, 2012
Last updated: October 20, 2014
Last verified: October 2014

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

Breast Cancer

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:
  • Xeloda dosage/schedule in routine clinical practice [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Regimen/concomitant medication used in routine clinical practice [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 274
Study Start Date: March 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with metastatic breast cancer initiated on therapy with Xeloda


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
  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 identifier: NCT01725386

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

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01725386     History of Changes
Other Study ID Numbers: ML25640
Study First Received: November 8, 2012
Last Updated: October 20, 2014
Health Authority: Pakistan: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on November 23, 2014