XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer

An observational study of Breast Cancer, run by Hoffmann-La Roche at 14 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
What is being tested?: capecitabine and docetaxel
How many people: 46 participants
Where: 14 sitesHungary
Study dates: Dec 2012to Dec 2014
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
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel

Who may be able to join

Adult participants, >/= 18 years of age
HER2-negative metastatic breast cancer
Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible

Who cannot join

Contraindications to Xeloda treatment according to the Summary of Product Characteristics

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Hungary14 sites

Study site
Budapest, 1067
Study site
Budapest, 1122
Study site
Budapest, 1125
Study site
Budapest, 1145
Study site
Debrecen, 4032
Study site
Gyula, 5700
Study site
Kaposvár, 7400
Study site
Kecskemét, 6000
Study site
Miskolc, 3501
Study site
Nyíregyháza, 4400
Study site
Szeged, 6720
Study site
Szombathely, 9700
Study site
Veszprém, 8200
Study site
Zalaegerszeg, 8900

Other trials in Hungary

About this study

Official title: Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)

Conditions: Breast Cancer
Being tested: capecitabine, docetaxel
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
Participants received capecitabine according to individualized physician-prescribed regimen.
docetaxelDrug
Participants received docetaxel according to individualized physician-prescribed regimens.

Study groups in NCT01777945
Study group	Role	What they receive
Participants Receiving Capecitabine/Docetaxel		Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens. Receives: Drug: capecitabine; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival (PFS)
The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.
Measured: approximately 2 years

Secondary outcomes (6)

Time to Treatment Failure
The time from enrollment to discontinuation of any drug of the treatment combination.
Measured: approximately 2 years
Overall Response Rate
The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.
Measured: approximately 2 years
Clinical Benefit Rate
The percentage of participants with an overall response (complete or partial remission) or with stable disease.
Measured: approximately 2 years
Duration of Treatment With Xeloda
Measured: approximately 2 years
Percentage of Capecitabine Dose Modifications
Measured: approximately 2 years
Number of Participants With Adverse Events
Measured: approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Dec 2014

First posted29 Jan 2013 (estimated)
Study startDec 2012
Primary completionDec 2014
Study completionDec 2014

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: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01777945
Sponsor's protocol ID: ML28505
Status last verified: Feb 2016
First submitted: 25 Jan 2013
Last updated: 19 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)
ClinicalTrials.gov ID: NCT01777945
Acronym / sponsor ID: ML28505
Conditions: Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 29 Jan 2013 (estimated)
Results: Posted 19 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants Receiving Capecitabine/Docetaxel	–	Drug: capecitabine, Drug: docetaxelParticipants received capecitabine and docetaxel according to individualized physician-prescribed regimens.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel

Key inclusion criteria (3 listed)

Adult participants, >/= 18 years of age
HER2-negative metastatic breast cancer
Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible

Key exclusion criteria (1 listed)

Contraindications to Xeloda treatment according to the Summary of Product Characteristics

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
capecitabineParticipants received capecitabine according to individualized physician-prescribed regimen.	Drug	Participants Receiving Capecitabine/Docetaxel
docetaxelParticipants received docetaxel according to individualized physician-prescribed regimens.	Drug	Participants Receiving Capecitabine/Docetaxel

Primary outcome

Progression-free Survival (PFS)
Time frame: approximately 2 years
The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.

6 secondary outcomes

Time to Treatment Failure
Time frame: approximately 2 years
Overall Response Rate
Time frame: approximately 2 years
Clinical Benefit Rate
Time frame: approximately 2 years
Duration of Treatment With Xeloda
Time frame: approximately 2 years
Percentage of Capecitabine Dose Modifications
Time frame: approximately 2 years
Number of Participants With Adverse Events
Time frame: approximately 2 years

Results and safety

Results posted to the registry on 19 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Receiving Capecitabine/Docetaxel	46	46

Primary outcome: Progression-free Survival (PFS)

Time frame: approximately 2 years. Median (Standard Deviation). Unit: months

Measure	Participants Receiving Capecitabine/Docetaxel n = 45
Value	9.89 (2.97)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Receiving Capecitabine/Docetaxel	8 of 46 (17.4%)	21 of 46 (45.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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

14 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 14 sites in Hungary.

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 3 inclusion and 1 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Hungary. 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 19 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?

Progression-free Survival (PFS) (time frame: approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01777945.

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 19 Aug 2016.