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

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Capecitabine

• Registration Number: NCT01725386
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2016-06-30
• Results First Submitted QC: 2016-06-30
• Status Verified: 2016-08
• Results First Posted: 2016-08-12
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 274

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monotherapy	Capecitabine	Capecitabine as monotherapy according to prescribing information and normal clinical practice.
Combination Therapy	Capecitabine	Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.

Primary Outcome Measures

Name	Time	Method
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy	Up to approximately 4 years	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.
Percentage of Participants Receiving Concomitant Medications During the Study	Up to approximately 4 years	Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline	Day 1	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.
Mean Survival Time	Up to approximately 4 years
Percentage of Participants With Relevant Medical History Assessed at Baseline	Day 1	To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.
Percentage of Participants With Adverse Events	Up to approximately 4 years