Breast CancerXEPADNCT01725386
An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer
An observational study of Breast Cancer, run by Hoffmann-La Roche at 15 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine
- How many people
- 274 participants
- Where
- 15 sitesPakistan
- Study dates
- Mar 2011to Feb 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with metastatic breast cancer initiated on therapy with capecitabine
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Pakistan15 sites
Study site
Abbottabad
Study site
Faisalabad
Study site
Gujranwala
Study site
Hyderābād
Study site
Islamabad, 44000
Study site
Islamabad
Study site
Karachi, 74700
Study site
Karachi, 75500
Study site
Karachi
Study site
Lahore, 54600
Study site
Lahore
Study site
Multan
Study site
Peshwar
Study site
Rawalpindi, 46000
Study site
Rawalpindi
About this study
Official title: Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer
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
- Being tested
- Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called XELODA
Oral tablet(s) administered according to prescribing information
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Capecitabine as monotherapy according to prescribing information and normal clinical practice. Receives: Drug: Capecitabine | |
| Combination Therapy | Capecitabine as part of combination therapy according to prescribing information and normal clinical practice. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 4 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: Day 1
Mean Survival Time
Measured: Up to approximately 4 years
Percentage of Participants With Adverse Events
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startMar 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725386
- Sponsor's protocol ID
- ML25640
- Acronym
- XEPAD
- Status last verified
- Aug 2016
- First submitted
- 8 Nov 2012
- Last updated
- 28 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01725386
- Acronym / sponsor ID
- XEPAD / ML25640
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Posted 12 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | – | Drug: CapecitabineCapecitabine as monotherapy according to prescribing information and normal clinical practice. |
| Combination Therapy | – | Drug: CapecitabineCapecitabine as part of combination therapy according to prescribing information and normal clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with metastatic breast cancer initiated on therapy with capecitabine
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: XELODAOral tablet(s) administered according to prescribing information | Drug | Combination Therapy, Monotherapy |
Primary outcome
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
Time frame: 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
Time frame: Up to approximately 4 years
Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.
4 secondary outcomes
Percentage of Participants With Relevant Medical History Assessed at Baseline
Time frame: Day 1
Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoffmann-La Roche at 15 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy (time frame: Up to approximately 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.