Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01725386
First received: November 8, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

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: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

  Eligibility

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

Criteria

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

Locations
Pakistan
Abbottabad, Pakistan
Faisalabad, Pakistan
Gujranwala, Pakistan
Hyderabad, Pakistan
Islamabad, Pakistan
Islamabad, Pakistan, 44000
Karachi, Pakistan, 74700
Karachi, Pakistan, 75500
Karachi, Pakistan
Lahore, Pakistan
Lahore, Pakistan, 54600
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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01725386     History of Changes
Other Study ID Numbers: ML25640
Study First Received: November 8, 2012
Last Updated: May 7, 2013
Health Authority: Pakistan: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013