Breast CancerPhase 2NCT00845910
A Study of Circulating Endothelial Cell as Marker for Avastin (Bevacizumab) in Combination With Docetaxel Plus Xeloda (Capecitabine) as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer
A Phase 2 study testing bevacizumab [Avastin], capecitabine [Xeloda] and docetaxel in people with Breast Cancer, run by Hoffmann-La Roche at 4 sites in Taiwan.
Trial summary
This single arm study will evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will be treated with docetaxel 60mg/m2 iv on day… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- bevacizumab [Avastin], capecitabine [Xeloda] and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesTaiwan
- Study dates
- May 2009to May 2011
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients, 18-65 years of age;
- locally recurrent and metastatic breast cancer;
- measurable or evaluable disease;
- ECOG performance status of 0-2;
- LVEF >=50% without clinical symptoms or signs of heart failure.
Who cannot join
- unknown HER2 status, or known HER2-positive status;
- prior chemotherapy for locally recurrent or metastatic disease;
- prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment;
- clinical or radiological evidence of CNS metastases;
- clinically significant cardiovascular disease.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Study site
Kaohsiung City, 807
Study site
Taichung, 404
Study site
Taichung, 407
Study site
Taoyuan, 333
About this study
Official title: A Phase II Trial of Evaluating Circulating Endothelial Cell as A Surrogate Marker for Monitoring Treatment Efficacy of Docetaxel Plus Capecitabine With Bevacizumab as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer
This single arm study will evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3 week cycle, plus Avastin 7.5 mg/kg iv on day 1 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
- bevacizumab [Avastin], capecitabine [Xeloda], 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.
bevacizumab [Avastin]Drug
7.5mg/kg iv on day 1 of every 3 week cycle
capecitabine [Xeloda]Drug
900mg/m2 po on days 1-14 of every 3 week cycle
docetaxelDrug
60mg/m2 iv on day 1 of every 3 week cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Every 12 weeks
Secondary outcomes (2)
Time to disease progression
Measured: Event driven
Serious adverse events
Measured: At planned visits, till disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: To be confirmed
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
- 22 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
- NCT00845910
- Sponsor's protocol ID
- ML21870
- Status last verified
- Nov 2016
- First submitted
- 17 Feb 2009
- 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 Phase II Trial of Evaluating Circulating Endothelial Cell as A Surrogate Marker for Monitoring Treatment Efficacy of Docetaxel Plus Capecitabine With Bevacizumab as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00845910
- Acronym / sponsor ID
- ML21870
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To be confirmed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Feb 2009 (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 evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3 week cycle, plus Avastin 7.5 mg/kg iv on day 1 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: bevacizumab [Avastin], Drug: capecitabine [Xeloda], Drug: docetaxel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female patients, 18-65 years of age;
- locally recurrent and metastatic breast cancer;
- measurable or evaluable disease;
- ECOG performance status of 0-2;
- LVEF >=50% without clinical symptoms or signs of heart failure.
Key exclusion criteria (5 listed)
- unknown HER2 status, or known HER2-positive status;
- prior chemotherapy for locally recurrent or metastatic disease;
- prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment;
- clinical or radiological evidence of CNS metastases;
- 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 |
|---|---|---|
| bevacizumab [Avastin]7.5mg/kg iv on day 1 of every 3 week cycle | Drug | 1 |
| capecitabine [Xeloda]900mg/m2 po on days 1-14 of every 3 week cycle | Drug | 1 |
| docetaxel60mg/m2 iv on day 1 of every 3 week cycle | Drug | 1 |
Primary outcome
Overall response rate
Time frame: Every 12 weeks
2 secondary outcomes
Time to disease progression
Time frame: Event driven
Serious adverse events
Time frame: At planned visits, till disease progression
Results and safety
The study was stopped early (reason given: To be confirmed). Results are not available in the source record.
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
4 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 bevacizumab [Avastin], capecitabine [Xeloda] and docetaxel in people with Breast Cancer, run by Hoffmann-La Roche at 4 sites in Taiwan.
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 5 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: stopped early, 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 4 sites in Taiwan. 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 was stopped early (reason given: To be confirmed). Results are not available in the source record.
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?
Overall response rate (time frame: Every 12 weeks). 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.