Metastatic Breast Cancer, Colon CancerNCT02479217
Safety of Xeloda in Solid Tumours
An observational study of Metastatic Breast Cancer, Colon Cancer, run by Hoffmann-La Roche at 1 site in Serbia.
Trial summary
The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Colon Cancer
- What is being tested?
- Docetaxel and Xeloda
- How many people
- 1,268 participants
- Where
- 1 siteSerbia
- Study dates
- Jul 2006to Jun 2009
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with early or metastatic colon cancer, and patients with metastatic breast cancer, no age limit
Who may be able to join
- Metastatic Breast Cancer:
- women >=18 years of age
- Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
- Previous therapy should have included an anthracycline.
- Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
- Female patients with histopathologically proven metastatic breast cancer
Show all 12Show fewer
- Adequate bone marrow, liver, renal and cardiac functions
- Colon Cancer:
- Patients >18 years of age
- Patients with histologicaly confirmed colon cancer
- Patients with potential curative tumor resection within 8 weeks before enrolment in the study
- Patients previously not treated with chemiotherapy
Who cannot join
- Metastatic Breast Cancer:
- Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda)
- Patients with contraindications for any of study drugs as listed in approved SmPC
- Colon Cancer:
- Patients previously treated with chemiotherapy
- Patients with contraindications for study drug as listed in approved SmPC
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.
- Conditions
- Metastatic Breast Cancer, Colon Cancer
- Being tested
- Docetaxel, Xeloda
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
XelodaDrug
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant therapy | Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer Receives: Drug: Xeloda | |
| Combination Therapy | Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression Receives: Drug: Docetaxel; Drug: Xeloda | |
| Monotherapy | Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer Receives: Drug: Xeloda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: within 18 months
Secondary outcomes (1)
Disease free survival (DFS)
Measured: within 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJul 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer, Colon 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,268 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
- NCT02479217
- Sponsor's protocol ID
- ML20367
- Status last verified
- Feb 2017
- First submitted
- 27 May 2015
- Last updated
- 17 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Xeloda in Solid Tumours
- ClinicalTrials.gov ID
- NCT02479217
- Acronym / sponsor ID
- ML20367
- Conditions
- Metastatic Breast Cancer, Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,268 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Jun 2015 (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.
The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adjuvant therapy | – | Drug: XelodaPatients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer |
| Combination Therapy | – | Drug: Docetaxel, Drug: XelodaPatients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression |
| Monotherapy | – | Drug: XelodaPatients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early or metastatic colon cancer, and patients with metastatic breast cancer, no age limit
Key inclusion criteria (12 listed)
- women >=18 years of age
- Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
- Previous therapy should have included an anthracycline.
- Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
- Female patients with histopathologically proven metastatic breast cancer
Key exclusion criteria (6 listed)
- Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda)
- Patients with contraindications for any of study drugs as listed in approved SmPC
- Patients previously treated with chemiotherapy
- Patients with contraindications for study drug as listed in approved SmPC
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 |
|---|---|---|
| Docetaxel | Drug | Combination Therapy |
| Xeloda | Drug | Adjuvant therapy, Combination Therapy, Monotherapy |
Primary outcome
Number of Participants with Adverse Events
Time frame: within 18 months
1 secondary outcome
Disease free survival (DFS)
Time frame: within 18 months
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 17 Feb 2017.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, Colon Cancer, run by Hoffmann-La Roche at 1 site in Serbia.
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 12 inclusion and 6 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. 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?
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?
Number of Participants with Adverse Events (time frame: within 18 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 17 Feb 2017.