Advanced Breast CancerPhase 2NCT00494481
E3 Breast Cancer Taxotere Combination
A Phase 2 study testing Vandetanib (ZD6474) and Docetaxel in people with Advanced Breast Cancer, run by Genzyme, a Sanofi Company at 12 sites in 5 countries.
Trial summary
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Vandetanib (ZD6474) and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Jan 2006to Jan 2009
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with histological/cytological confirmation of breast cancer.
- Subjects with a measurable lesion or bone lesions
Who cannot join
- Previous radiotherapy within 6 weeks
- Significant cardiac events, arrhythmias or other cardiac conditions
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
South Africa3 sites
Research SIte
Bloemfontein
Research Site
Cape Town
Research Site
Observatory
About this study
Official title: A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology
- Conditions
- Advanced Breast Cancer
- Being tested
- Vandetanib (ZD6474), Docetaxel
- Keywords
- Zactima
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vandetanib (ZD6474)Drug
Also called ZACTIMA™
once daily oral dose
DocetaxelDrug
Also called Taxotere®
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Docetaxel + placebo vandetanib Receives: Drug: Docetaxel |
| 2 | Experimental | Vandetanib + Docetaxel Receives: Drug: Vandetanib (ZD6474); Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With a Disease Progression Event
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Measured: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJan 2006
- Primary completionJun 2007
- Study completionJan 2009
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 Advanced 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494481
- Sponsor's protocol ID
- D4200C00046
- Other IDs
- 2005-003592-20, 2005
- Status last verified
- Aug 2016
- First submitted
- 28 Jun 2007
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).
- ClinicalTrials.gov ID
- NCT00494481
- Acronym / sponsor ID
- D4200C00046
- Conditions
- Advanced Breast Cancer
- Keywords
- Zactima
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Posted 24 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: DocetaxelDocetaxel + placebo vandetanib |
| 2 | Experimental | Drug: Vandetanib (ZD6474), Drug: DocetaxelVandetanib + Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females with histological/cytological confirmation of breast cancer.
- Subjects with a measurable lesion or bone lesions
Key exclusion criteria (2 listed)
- Previous radiotherapy within 6 weeks
- Significant cardiac events, arrhythmias or other cardiac conditions
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 |
|---|---|---|
| Vandetanib (ZD6474)Also: ZACTIMA™once daily oral dose | Drug | 2 |
| DocetaxelAlso: Taxotere®intravenous infusion | Drug | 1, 2 |
Primary outcome
Number of Patients With a Disease Progression Event
Time frame: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Sciences & Operations study director
Sanofi
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vandetanib (ZD6474) and Docetaxel in people with Advanced Breast Cancer, run by Genzyme, a Sanofi Company at 12 sites in 5 countries.
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 2 inclusion and 2 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 30 Sep 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 South Africa, Spain, Sweden, Hungary, 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 May 2011). 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?
Number of Patients With a Disease Progression Event (time frame: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off). 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 30 Sep 2016.