Metastatic Breast CancerPhase 2NCT00467012
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
A Phase 2 study testing bevacizumab and Paclitaxel in people with Metastatic Breast Cancer, run by Chugai Pharmaceutical at 5 sites in Japan.
Trial summary
To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- bevacizumab and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 5 sitesJapan
- Study dates
- Apr 2007to Sep 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
- At least 20 years old and obtained a written informed consent
- Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer
- HER2 negative
- At least one measurable lesion based on RECIST criteria
- No previous chemotherapy for metastatic breast cancer
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Kanto Region
Kanto
Kinki Region
Kinki
Kyushu region
Kyushu
Sikoku region
Sikoku
Tohoku region
Tōhoku
About this study
To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- bevacizumab, Paclitaxel
- Keywords
- Inoperable metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
10mg/kg，Day1, 15 of 1 cycle(4 weeks)
PaclitaxelDrug
90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| step 1 | Experimental | 6 enrollment for 1 cycle(4 weeks) Receives: Drug: bevacizumab; Drug: Paclitaxel |
| step 2 | Experimental | 114 enrollment through to meet the stopping criteria Receives: Drug: bevacizumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: throughout study
Progression-free survival (PFS)
Measured: event driven
Secondary outcomes (3)
Overall Survival(OS)
Measured: event driven
Time to Treatment Failure(TTF)
Measured: evnt driven
Response Rate(RR)
Measured: event driven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shingo Koganezawa, Study chair, Clinical research department 3
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467012
- Sponsor's protocol ID
- JO19901
- Status last verified
- Apr 2012
- First submitted
- 26 Apr 2007
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00467012
- Acronym / sponsor ID
- JO19901
- Conditions
- Metastatic Breast Cancer
- Keywords
- Inoperable metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Apr 2007 (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.
To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| step 1 | Experimental | Drug: bevacizumab, Drug: Paclitaxel6 enrollment for 1 cycle(4 weeks) |
| step 2 | Experimental | Drug: bevacizumab, Drug: Paclitaxel114 enrollment through to meet the stopping criteria |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bevacizumab10mg/kg，Day1, 15 of 1 cycle(4 weeks) | Drug | step 1, step 2 |
| Paclitaxel90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks) | Drug | step 1, step 2 |
Primary outcome
Safety
Time frame: throughout study
Progression-free survival (PFS)
Time frame: event driven
3 secondary outcomes
Overall Survival(OS)
Time frame: event driven
Time to Treatment Failure(TTF)
Time frame: evnt driven
Response Rate(RR)
Time frame: event driven
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 26 Apr 2012.
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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.
Shingo Koganezawa study chair
Clinical research department 3
5 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 and Paclitaxel in people with Metastatic Breast Cancer, run by Chugai Pharmaceutical at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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?
Safety (time frame: throughout study). 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 26 Apr 2012.