Breast CancerPhase 2NCT01077726
A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression
A Phase 2 study testing capecitabine [Xeloda] in people with Breast Cancer, run by Hoffmann-La Roche at 12 sites in France.
Trial summary
This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. 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 [Xeloda]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 12 sitesFrance
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- female patients, >=18 years of age;
- breast cancer;
- CNS progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
- at least one measurable lesion;
- ECOG performance status 0-2.
Who cannot join
- prior systemic treatment of brain metastases;
- prior disease progression while on Xeloda treatment;
- previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
- clinically significant cardiovascular disease.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Study site
Angers, 49055
Study site
Arras, 62000
Study site
Béziers, 34500
Study site
Bobigny, 93009
Study site
Caen, 14076
Study site
Lille, 59020
Study site
Lyon, 69373
Study site
Narbonne, 11780
Study site
Nice, 06000
Study site
Paris, 75475
Study site
Paris, 75651
Study site
Salouël, 80480
About this study
Official title: A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy
This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
- Conditions
- Breast Cancer
- Being tested
- capecitabine [Xeloda]
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine [Xeloda]Drug
1000mg/m2 po bid on days 1-14 of each 3 week cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: capecitabine [Xeloda] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 4 months
Secondary outcomes (7)
Objective Central Nervous System (CNS) response
Measured: From first administration of study treatment until documented CNS recurrence or progression
Duration of CNS response
Measured: From time of first documented cranial complete response (CR) or partial response (PR) (whichever is recorded first) until the first date CNS recurrence or progression is documented
Cranial PFS
Measured: From the first administration of study treatment to the time of documented cranial recurrence or progression\n
Progression-free survival\n
Measured: From the first administration of study treatment to the time of documented recurrence or progression\n
Clinical benefit \n
Measured: From first administration of study treatment to study end (12 Months)
Extra-cranial disease response rate\n
Measured: From first administration of study treatment to the time of documented extra-cranial recurrence or progression
Overall Survival (OS)\n
Measured: From first administration of study treatment to the time of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT01077726
- Sponsor's protocol ID
- ML22203
- Other IDs
- 2008-007350-35, 2008
- Status last verified
- Nov 2016
- First submitted
- 15 Jan 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy
- ClinicalTrials.gov ID
- NCT01077726
- Acronym / sponsor ID
- ML22203
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: capecitabine [Xeloda] |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female patients, >=18 years of age;
- breast cancer;
- CNS progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
- at least one measurable lesion;
- ECOG performance status 0-2.
Key exclusion criteria (4 listed)
- prior systemic treatment of brain metastases;
- prior disease progression while on Xeloda treatment;
- previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
- clinically significant cardiovascular disease.
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 |
|---|---|---|
| capecitabine [Xeloda]1000mg/m2 po bid on days 1-14 of each 3 week cycle | Drug | 1 |
Primary outcome
Progression-free survival
Time frame: 4 months
7 secondary outcomes
Objective Central Nervous System (CNS) response
Time frame: From first administration of study treatment until documented CNS recurrence or progression
Duration of CNS response
Time frame: From time of first documented cranial complete response (CR) or partial response (PR) (whichever is recorded first) until the first date CNS recurrence or progression is documented
Cranial PFS
Time frame: From the first administration of study treatment to the time of documented cranial recurrence or progression\n
Progression-free survival\n
Time frame: From the first administration of study treatment to the time of documented recurrence or progression\n
Clinical benefit \n
Time frame: From first administration of study treatment to study end (12 Months)
Extra-cranial disease response rate\n
Time frame: From first administration of study treatment to the time of documented extra-cranial recurrence or progression
Overall Survival (OS)\n
Time frame: From first administration of study treatment to the time of death from any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine [Xeloda] in people with Breast Cancer, run by Hoffmann-La Roche at 12 sites in France.
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 5 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 4 months). 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 2 Nov 2016.