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

NCT01725386 | Completed Results

• 1 other identifier: ML25640
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 15

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 4 years

Secondary Outcomes (4)

• Percentage of Participants With Relevant Medical History Assessed at Baseline

  Day 1

• Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline

  Day 1

• Mean Survival Time

  Up to approximately 4 years

• Percentage of Participants With Adverse Events

  Up to approximately 4 years

Study Arms (2)

Monotherapy

Capecitabine as monotherapy according to prescribing information and normal clinical practice.

Drug: Capecitabine

Combination Therapy

Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.

Drug: Capecitabine

Interventions

Capecitabine DRUG

Oral tablet(s) administered according to prescribing information

Also known as: XELODA

Combination Therapy; Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with metastatic breast cancer initiated on therapy with capecitabine

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Unknown Facility

Abbottabad, Pakistan

Location

Unknown Facility

Faisalabad, Pakistan

Location

Unknown Facility

Gujranwala, Pakistan

Location

Unknown Facility

Hyderābād, Pakistan

Location

Unknown Facility

Islamabad, 44000, Pakistan

Location

Unknown Facility

Islamabad, Pakistan

Location

Unknown Facility

Karachi, 74700, Pakistan

Location

Unknown Facility

Karachi, 75500, Pakistan

Location

Unknown Facility

Karachi, Pakistan

Location

Unknown Facility

Lahore, 54600, Pakistan

Location

Unknown Facility

Lahore, Pakistan

Location

Unknown Facility

Multan, Pakistan

Location

Unknown Facility

Peshwar, Pakistan

Location

Unknown Facility

Rawalpindi, 46000, Pakistan

Location

Unknown Facility

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: March 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: September 28, 2016
• Results First Posted: August 12, 2016

Record last verified: 2016-08

Locations

PA (15)