Breast NeoplasmsPhase 3NCT00300508
3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer
A Phase 3 study testing Anastrozole in people with Breast Neoplasms, run by AstraZeneca at 51 sites in Austria.
Trial summary
The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Anastrozole
- How many people
- 856 participants
- Where
- 51 sitesAustria
- Study dates
- Jan 1996to not given
- 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No disease recurrence at time of randomization,
- patients with breast cancer after surgery,
- 5 years (+/- 12 months) of prior endocrine therapy
Who cannot join
- Premenopausal patients,
- unknown or negative receptor status,
- Secondary malignant tumor
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
Austria51 sites
Research Site
Amstetten
Research Site
Bad Ischl
Research Site
Baden
Research Site
Bregenz
Research Site
Bruck an der Mur
Research Site
Dornbirn
Research Site
Eisenstadt
Research Site
Feldbach
Research Site
Feldkirch
Research Site
Freistadt
Research Site
Fürstenfeld
Research Site
Graz
Research Site
Guessing
Research Site
Hainburg an der Donau
Research Site
Hartberg
Research site
Hollabrunn
Research Site
Horn
Research Site
Innsbruck
Research Site
Kirchdorf
Research Site
Klagenfurt
Research Site
Klosterneuburg
Research Site
Krems
Research Site
Kufstein
Research Site
Leoben
Research Site
Linz
Research Site
Mistelbach
Research Site
Mödling
Research Site
Neunkirche
Research Site
Oberpullendorf
Research Site
Oberwart
Research Site
Ried im Innkreis
Research Site
Rohrbach
Research Site
Rottenmann
Research Site
Salzburg
Research Site
Sankt Pölten
Research Site
Sankt Veit an der Glan
Research Site
Schaerding
Research Site
Scheibbs
Research Site
Schladming
Research Site
Schwarzach
Research Site
Spittal an der Drau
Research Site
Steyr
Research Site
Tulln
Research Site
Vienna
Research Site
Villach
Research Site
Vöcklabruck
Research Site
Waidhofen an der Ybbs
Research Site
Wels
Research Site
Wiener Neustadt
Research Site
Wolfsberg
Research Site
Zams
About this study
Official title: A Randomized, Open, Comparative Multicentre Trial of 3 Years Anastrozole Treatment vs. 3 Years no Treatment in Postmenopausal Patients With Breast Cancer Who Have Completed 5 Years Adjuvant Hormone Therapy.
The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.
- Conditions
- Breast Neoplasms
- Being tested
- Anastrozole
- Keywords
- Hormone receptor positive 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.
AnastrozoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free and overall survival
Secondary outcomes (1)
Secondary cancers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startJan 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- None (open label)
- Enrolment
- 856 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Austria Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300508
- Sponsor's protocol ID
- 1033AU/0001
- Other IDs
- ABCSG 6A
- Status last verified
- Apr 2009
- First submitted
- 7 Mar 2006
- Last updated
- 1 May 2009
- Results posted
- No
Publications
Wimmer K, Hlauschek D, Balic M, Pfeiler G, Greil R, Singer CF, Halper S, Steger G, Suppan C, Gampenrieder SP, Helfgott R, Egle D, Filipits M, Jakesz R, Solkner L, Fesl C, Gnant M, Fitzal F. Is the CTS5 a helpful decision-making tool in the extended adjuvant therapy setting? Breast Cancer Res Treat. 2024 Jun;205(2):227-239. doi: 10.1007/s10549-023-07186-6. Epub 2024 Jan 25.
PubMed 38273214Gnant M, Pfeiler G, Stoger H, Mlineritsch B, Fitzal F, Balic M, Kwasny W, Seifert M, Stierer M, Dubsky P, Greil R, Steger G, Samonigg H, Fesl C, Jakesz R. The predictive impact of body mass index on the efficacy of extended adjuvant endocrine treatment with anastrozole in postmenopausal patients with breast cancer: an analysis of the randomised ABCSG-6a trial. Br J Cancer. 2013 Aug 6;109(3):589-96. doi: 10.1038/bjc.2013.367. Epub 2013 Jul 18.
PubMed 23868011
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Comparative Multicentre Trial of 3 Years Anastrozole Treatment vs. 3 Years no Treatment in Postmenopausal Patients With Breast Cancer Who Have Completed 5 Years Adjuvant Hormone Therapy.
- ClinicalTrials.gov ID
- NCT00300508
- Acronym / sponsor ID
- 1033AU/0001
- Conditions
- Breast Neoplasms
- Keywords
- Hormone receptor positive breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 856 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 1996
- First posted
- 9 Mar 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.
The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- No disease recurrence at time of randomization,
- patients with breast cancer after surgery,
- 5 years (+/- 12 months) of prior endocrine therapy
Key exclusion criteria (3 listed)
- Premenopausal patients,
- unknown or negative receptor status,
- Secondary malignant tumor
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 |
|---|---|---|
| Anastrozole | Drug | – |
Primary outcome
Recurrence-free and overall survival
1 secondary outcome
Secondary cancers
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 1 May 2009.
- Derived from this study: PubMed 38273214Wimmer K, Hlauschek D, Balic M, Pfeiler G, Greil R, Singer CF, Halper S, Steger G, Suppan C, Gampenrieder SP, Helfgott R, Egle D, Filipits M, Jakesz R, Solkner L, Fesl C, Gnant M, Fitzal F. Is the CTS5 a helpful decision-making tool in the extended adjuvant therapy setting? Breast Cancer Res Treat. 2024 Jun;205(2):227-239. doi: 10.1007/s10549-023-07186-6. Epub 2024 Jan 25.
- Derived from this study: PubMed 23868011Gnant M, Pfeiler G, Stoger H, Mlineritsch B, Fitzal F, Balic M, Kwasny W, Seifert M, Stierer M, Dubsky P, Greil R, Steger G, Samonigg H, Fesl C, Jakesz R. The predictive impact of body mass index on the efficacy of extended adjuvant endocrine treatment with anastrozole in postmenopausal patients with breast cancer: an analysis of the randomised ABCSG-6a trial. Br J Cancer. 2013 Aug 6;109(3):589-96. doi: 10.1038/bjc.2013.367. Epub 2013 Jul 18.
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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.
AstraZeneca Austria Medical Director, MD study director
AstraZeneca
51 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 Anastrozole in people with Breast Neoplasms, run by AstraZeneca at 51 sites in Austria.
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 3 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 1 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Austria. 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?
Recurrence-free and overall survival. 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 NCT00300508, which also lists 2 linked publications.
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 1 May 2009.