Advanced Breast CancerPhase 2NCT00454805
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
A Phase 2 study testing AZD2171 and Fulvestrant in people with Advanced Breast Cancer, run by AstraZeneca at 16 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy. Read more about this study
- Who is it for?
- Ages 18 to 130 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- AZD2171 and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Mar 2007to Apr 2016
- 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 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease
- One or more evaluable lesions
Who cannot join
- Prior hormonal therapy with fulvestrant
- More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer
- Prior biologic therapy for ABC including Anti-VEGF agents
- Radiation therapy within 4 weeks prior to provision of consent
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States6 sites
Research Site
Boca Raton, Florida
Research Site
Burbank, California
Research Site
Honolulu, Hawaii
Research Site
Los Angeles, California
Research Site
New York, New York
Research Site
Palm Springs, California
Brazil6 sites
Research Site
Belo Horizonte
Research Site
Curitiba
Research Site
Fortaleza
Research Site
Porto Alegre
Research Site
Santro Andre
Research Site
São Paulo
Australia4 sites
Research Site
Fitzroy
Research Site
Parkville
Research Site
Perth
Research Site
Waratah
About this study
Official title: A Phase II, Double-Blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of AZD2171 in Combination With Fulvestrant vs Fulvestrant Alone in Hormone Sensitive (ER+ve or PgR+ve) Post Menopausal Metastatic Breast Cancer Patients
The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.
- Conditions
- Advanced Breast Cancer
- Being tested
- AZD2171, Fulvestrant
- Keywords
- Advanced Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2171Drug
Also called Recentin
Oral tablet
FulvestrantDrug
Also called Faslodex, ZD9238
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Fulvestrant Monotherapy Receives: Drug: Fulvestrant |
| 3 | Experimental | AZD2171 + Fulvestrant Receives: Drug: AZD2171; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Measured: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Secondary outcomes (4)
Objective Response Rate
Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as:
Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase.
Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Measured: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Duration of Response
Number of days from date of response (complete/partial based on RECIST) to date of progression
Measured: Every 8 weeks until progression or discontinuation
Clinical Benefit Rate
Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months.
The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off.
Measured: Every 8 weeks until progression or discontinuation
Duration of Clinical Benefit
Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months.
Measured: Every 8 weeks until progression or discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionApr 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bijoyesh Mookerjee, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454805
- Sponsor's protocol ID
- D8480C00007
- Status last verified
- Jul 2016
- First submitted
- 29 Mar 2007
- Last updated
- 3 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P. Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs. 2013 Oct;31(5):1345-54. doi: 10.1007/s10637-013-9991-2. Epub 2013 Jun 26.
PubMed 23801303
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 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 AZD2171 in Combination With Fulvestrant vs Fulvestrant Alone in Hormone Sensitive (ER+ve or PgR+ve) Post Menopausal Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00454805
- Acronym / sponsor ID
- D8480C00007
- Conditions
- Advanced Breast Cancer
- Keywords
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Apr 2007 (estimated)
- Results
- Posted 28 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.
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 |
|---|---|---|
| 2 | Active comparator | Drug: FulvestrantFulvestrant Monotherapy |
| 3 | Experimental | Drug: AZD2171, Drug: FulvestrantAZD2171 + Fulvestrant |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease
- One or more evaluable lesions
Key exclusion criteria (4 listed)
- Prior hormonal therapy with fulvestrant
- More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer
- Prior biologic therapy for ABC including Anti-VEGF agents
- Radiation therapy within 4 weeks prior to provision of consent
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 |
|---|---|---|
| AZD2171Also: RecentinOral tablet | Drug | 3 |
| FulvestrantAlso: Faslodex, ZD9238intramuscular injection | Drug | 2, 3 |
Primary outcome
Progression Free Survival
Time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
4 secondary outcomes
Objective Response Rate
Time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Duration of Response
Time frame: Every 8 weeks until progression or discontinuation
Clinical Benefit Rate
Time frame: Every 8 weeks until progression or discontinuation
Duration of Clinical Benefit
Time frame: Every 8 weeks until progression or discontinuation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23801303Hyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P. Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs. 2013 Oct;31(5):1345-54. doi: 10.1007/s10637-013-9991-2. Epub 2013 Jun 26.
- CSR-D8480C00007.pdfLink provided by the sponsor.
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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.
Bijoyesh Mookerjee, MD study director
AstraZeneca
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD2171 and Fulvestrant in people with Advanced Breast Cancer, run by AstraZeneca at 16 sites in 3 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 3 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 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Brazil, Australia. 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?
Yes. Results are posted in the registry (first posted 28 Nov 2012). 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?
Progression Free Survival (time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00454805, which also lists 1 linked publication.
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 3 Aug 2016.