Progression-free SurvivalPhase 3NCT00944918
Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
A Phase 3 study testing fulvestrant, anastrozole and exemestane in people with Progression-free Survival, run by AstraZeneca at 2 sites in South Korea.
Trial summary
A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Progression-free Survival
- What is being tested?
- fulvestrant, anastrozole and exemestane
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2008to Jun 2011
- 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
- Histologically or cytologically confirmed adenocarcinoma of the breast.
- Metastatic disease must be measurable or evaluable
- Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
- NSAI given as adjuvant therapy that lasted ≥ 12 months OR
- Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
- Female postmenopausal patients
Who cannot join
- Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
- Prescribed Tamoxifen for metastatic disease
- Rapidly progressive visceral disease
- Patients with malignancies within the last 5 years.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors
A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.
- Conditions
- Progression-free Survival
- Being tested
- fulvestrant, anastrozole, exemestane
- Keywords
- 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.
fulvestrantDrug
Also called Faslodex
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
anastrozoleDrug
Also called Arimidex
Tablet, oral, once daily until disease progression.
exemestaneDrug
Also called Aromasin
Tablet, oral, once daily until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fulvestrant and anastrozole Receives: Drug: fulvestrant; Drug: anastrozole |
| 2 | Experimental | fulvestrant and placebo Receives: Drug: fulvestrant |
| 3 | Active comparator | exemestane alone Receives: Drug: exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: every 3 months during treatment and, at time of discontinuation from treatment
Secondary outcomes (3)
Objective complete response (CR) and partial response (PR) rate
Measured: every 3 months during treatment and, at time of discontinuation from treatment
Duration of response
Measured: every 3 months during treatment and, at time of discontinuation from treatment
Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate
Measured: every 3 months during treatment and, at time of discontinuation from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2011
- Study completionJun 2011
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 Progression-free SurvivalStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Huck Im, Principal investigator, Professor(Samsung Medical Center)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944918
- Sponsor's protocol ID
- 9238UK/0005
- Status last verified
- Aug 2011
- First submitted
- 22 Jul 2009
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.
PubMed 23902874
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT00944918
- Acronym / sponsor ID
- 9238UK/0005
- Conditions
- Progression-free Survival
- Keywords
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jul 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.
A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fulvestrant, Drug: anastrozolefulvestrant and anastrozole |
| 2 | Experimental | Drug: fulvestrantfulvestrant and placebo |
| 3 | Active comparator | Drug: exemestaneexemestane alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed adenocarcinoma of the breast.
- Metastatic disease must be measurable or evaluable
- Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
- NSAI given as adjuvant therapy that lasted ≥ 12 months OR
- Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
Key exclusion criteria (4 listed)
- Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
- Prescribed Tamoxifen for metastatic disease
- Rapidly progressive visceral disease
- Patients with malignancies within the last 5 years.
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: FaslodexIntramuscular injection on days 1, 15, and 29 and then once monthly until disease progression. | Drug | 1, 2 |
| anastrozoleAlso: ArimidexTablet, oral, once daily until disease progression. | Drug | 1 |
| exemestaneAlso: AromasinTablet, oral, once daily until disease progression. | Drug | 3 |
Primary outcome
Progression-free survival
Time frame: every 3 months during treatment and, at time of discontinuation from treatment
3 secondary outcomes
Objective complete response (CR) and partial response (PR) rate
Time frame: every 3 months during treatment and, at time of discontinuation from treatment
Duration of response
Time frame: every 3 months during treatment and, at time of discontinuation from treatment
Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate
Time frame: every 3 months during treatment and, at time of discontinuation from treatment
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 29 Aug 2011.
- Derived from this study: PubMed 23902874Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.
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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.
Young-Huck Im principal investigator
Professor(Samsung Medical Center)
2 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, anastrozole and exemestane in people with Progression-free Survival, run by AstraZeneca at 2 sites in South Korea.
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 6 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 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Progression-free survival (time frame: every 3 months during treatment and, at time of discontinuation from treatment). 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 NCT00944918, 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 29 Aug 2011.