Advanced Breast CancerPhase 3NCT00327769
Faslodex Advanced Breast Cancer Local Chinese Study
A Phase 3 study testing Fulvestrant and Anastrozole in people with Advanced Breast Cancer, run by AstraZeneca at 12 sites in China.
Trial summary
This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer. 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?
- Fulvestrant and Anastrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 12 sitesChina
- Study dates
- Nov 2005to Sep 2007
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal advanced breast cancer with oestrogen receptor positive
- Progression under first-line anti-oestrogen therapy.
Who cannot join
- Life-threatening metastasis; contraindication to anastrozole
- >2 regimens of hormonotherapy for advanced breast cancer
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Research Site
Beijing
Research Site
Dalian
Research Site
Fuzhou
Research Site
Guangzhou
Research Site
Hankou
Research Site
Hefei
Research Site
Huangzhou
Research Site
Jinan
Research Site
Nanjing
Research Site
Shanghai
Research Site
Wuhan
Research Site
Xi'an
About this study
Official title: A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- Fulvestrant, Anastrozole
- Keywords
- Advanced breast cancer, fulvestrant, anastrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Faslodex, ZD9238
250 mg intramuscular injection
AnastrozoleDrug
Also called Arimidex, ZD1033
1 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Anastrozole Receives: Drug: Anastrozole |
| 2 | Experimental | Anastrozole + Fulvestrant Receives: Drug: Fulvestrant; Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression (TTP)
Secondary outcomes (4)
Objective Response Rate (ORR)
Clinical Benefit Rate (CBR)
Time to Treatment Failure (TTF)
Safety & Tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startNov 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Breast Cancer Established Brands Team Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327769
- Sponsor's protocol ID
- D6997L00004
- Status last verified
- Jan 2011
- First submitted
- 18 May 2006
- Last updated
- 25 Jan 2011
- Results posted
- No
Publications
Xu B, Jiang Z, Shao Z, Wang J, Feng J, Song S, Chen Z, Gu K, Yu S, Zhang Y, Wang C, Zhang F, Yang J. Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):223-30. doi: 10.1007/s00280-010-1483-x. Epub 2010 Oct 12.
PubMed 20938664
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00327769
- Acronym / sponsor ID
- D6997L00004
- Conditions
- Advanced Breast Cancer
- Keywords
- Advanced breast cancer, fulvestrant, anastrozole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 19 May 2006 (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 study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.
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 | Active comparator | Drug: AnastrozoleAnastrozole |
| 2 | Experimental | Drug: Fulvestrant, Drug: AnastrozoleAnastrozole + Fulvestrant |
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)
- Postmenopausal advanced breast cancer with oestrogen receptor positive
- Progression under first-line anti-oestrogen therapy.
Key exclusion criteria (2 listed)
- Life-threatening metastasis; contraindication to anastrozole
- >2 regimens of hormonotherapy for advanced breast cancer
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 |
|---|---|---|
| FulvestrantAlso: Faslodex, ZD9238250 mg intramuscular injection | Drug | 2 |
| AnastrozoleAlso: Arimidex, ZD10331 mg tablet | Drug | 1, 2 |
Primary outcome
Time to Disease Progression (TTP)
4 secondary outcomes
Objective Response Rate (ORR)
Clinical Benefit Rate (CBR)
Time to Treatment Failure (TTF)
Safety & Tolerability.
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 25 Jan 2011.
- Derived from this study: PubMed 20938664Xu B, Jiang Z, Shao Z, Wang J, Feng J, Song S, Chen Z, Gu K, Yu S, Zhang Y, Wang C, Zhang F, Yang J. Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):223-30. doi: 10.1007/s00280-010-1483-x. Epub 2010 Oct 12.
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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.
Breast Cancer Established Brands Team Medical Science Director, MD study director
AstraZeneca
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fulvestrant and Anastrozole in people with Advanced Breast Cancer, run by AstraZeneca at 12 sites in China.
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 25 Jan 2011. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to Disease Progression (TTP). 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 NCT00327769, 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 25 Jan 2011.