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

Hoffmann-La Roche274 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

274

Conditions

Breast Cancer

Interventions

CapecitabineDRUG

Oral tablet(s) administered according to prescribing information

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Unnamed facility

Abbottabad, Pakistan

Unnamed facility

Faisalabad, Pakistan

Unnamed facility

Gujranwala, Pakistan

Unnamed facility

Hyderābād, Pakistan

Outcomes

Primary Outcomes

Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy

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.

Time frame: Up to approximately 4 years

Percentage of Participants Receiving Concomitant Medications During the Study

Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.

Time frame: Up to approximately 4 years

Secondary Outcomes

Percentage of Participants With Relevant Medical History Assessed at Baseline

To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.

Time frame: Day 1

Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline

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.

Time frame: Day 1

Mean Survival Time

Time frame: Up to approximately 4 years

Percentage of Participants With Adverse Events

Time frame: Up to approximately 4 years

Data from ClinicalTrials.gov

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