Breast CancerPhase 3NCT00291759
ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.
A Phase 3 study testing Tamoxifen and Anastrozole in people with Breast Cancer, run by AstraZeneca at 52 sites in Austria.
Trial summary
The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen and Anastrozole
- How many people
- 3,858 participants
- Where
- 52 sitesAustria
- Study dates
- Jan 1996to Jun 2009
- 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
- Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.
- At least 6 lymph nodes examined.
- Good or intermediate tumour differentiation.
- <6 weeks before start of adjuvant therapy.
- Oestrogen or Progesterone positive
Who cannot join
- Premenopausal.
- Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.
- In-situ/T4 carcinoma.
- Age >80 years.
- World Health Organisation performance index >3.
- Serious accompanying diseases
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
Austria52 sites
Research Site
Amstetten
Research Site
Bad Ischl
Research Site
Baden
Research Site
Bregenz
Research Site
Bruck/Mur
Research Site
Dornbirn
Research Site
Eisenstadt
Research Site
Feldbach
Research Site
Feldkirch
Research Site
Freistadt
Research Site
Fürstenfeld
Research Site
Gmünd
Research Sites
Graz
Research Site
Guessing
Research Site
Hainburg an der Donau
Research Site
Hartberg
Research Site
Hollabrunn
Research Site
Horn
Research Site
Innsbruck
Research Site
Judenburg
Research Site
Kirchdorf
Research Site
Klagenfurt
Research Sites
Klosterneuburg
Research Site
Kufstein
Research Site
Leoben
Research Sites
Linz
Research SIte
Melk
Research Site
Mistelbach
Research Site
Mödling
Research Site
Neunkirchen
Research Site
Oberpullendorf
Research Site
Oberwart
Research Site
Ried im Innkreis
Research Site
Rohrbach
Research Site
Rottenmann
Research Site
Saint Poelton
Research Site
Saint Veit/Glan
Research Site
Salzburg
Research Site
Schaerding
Research Site
Scheibbs
Research Site
Schladming
Research Site
Schwarzach/Pongau
Research Site
Spittal/Drau
Research Site
Steyr
Research Site
Tulln
Research Sites
Vienna
Research Site
Villach
Research Site
Vöcklabruck
Research Site
Waidhofen/Thaya
Research Site
Wels
Research Site
Wolfsberg
Research Site
Zams
About this study
Official title: Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years.
The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen, Anastrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
AnastrozoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.
Secondary outcomes (1)
To assess the difference in event free survival & overall survival (subject to stand-alone or combined/meta-analysis) plus side effects between postmenopausal women with HR+ve early BC who switched from tam to anastrozole and those who continued on tam.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJan 1996
- Primary completionJun 2009
- Study completionJun 2009
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 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
- None (open label)
- Enrolment
- 3,858 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raimund Jakesz, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study GroupAstraZeneca Austria Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291759
- Sponsor's protocol ID
- 1033AU/0002
- Other IDs
- ABCSG 8
- Status last verified
- Jan 2013
- First submitted
- 13 Feb 2006
- Last updated
- 30 Jan 2013
- Results posted
- No
Publications
Sestak I, Cuzick J, Dowsett M, Lopez-Knowles E, Filipits M, Dubsky P, Cowens JW, Ferree S, Schaper C, Fesl C, Gnant M. Prediction of late distant recurrence after 5 years of endocrine treatment: a combined analysis of patients from the Austrian breast and colorectal cancer study group 8 and arimidex, tamoxifen alone or in combination randomized trials using the PAM50 risk of recurrence score. J Clin Oncol. 2015 Mar 10;33(8):916-22. doi: 10.1200/JCO.2014.55.6894. Epub 2014 Oct 20.
PubMed 25332252Gnant M, Filipits M, Greil R, Stoeger H, Rudas M, Bago-Horvath Z, Mlineritsch B, Kwasny W, Knauer M, Singer C, Jakesz R, Dubsky P, Fitzal F, Bartsch R, Steger G, Balic M, Ressler S, Cowens JW, Storhoff J, Ferree S, Schaper C, Liu S, Fesl C, Nielsen TO; Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014 Feb;25(2):339-45. doi: 10.1093/annonc/mdt494. Epub 2013 Dec 16.
PubMed 24347518
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years.
- ClinicalTrials.gov ID
- NCT00291759
- Acronym / sponsor ID
- 1033AU/0002
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,858 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 1996
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Feb 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 purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.
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 (5 listed)
- Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.
- At least 6 lymph nodes examined.
- Good or intermediate tumour differentiation.
- <6 weeks before start of adjuvant therapy.
- Oestrogen or Progesterone positive
Key exclusion criteria (6 listed)
- Premenopausal.
- Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.
- In-situ/T4 carcinoma.
- Age >80 years.
- World Health Organisation performance index >3.
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 |
|---|---|---|
| Tamoxifen | Drug | – |
| Anastrozole | Drug | – |
Primary outcome
To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.
1 secondary outcome
To assess the difference in event free survival & overall survival (subject to stand-alone or combined/meta-analysis) plus side effects between postmenopausal women with HR+ve early BC who switched from tam to anastrozole and those who continued on tam.
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 30 Jan 2013.
- Derived from this study: PubMed 25332252Sestak I, Cuzick J, Dowsett M, Lopez-Knowles E, Filipits M, Dubsky P, Cowens JW, Ferree S, Schaper C, Fesl C, Gnant M. Prediction of late distant recurrence after 5 years of endocrine treatment: a combined analysis of patients from the Austrian breast and colorectal cancer study group 8 and arimidex, tamoxifen alone or in combination randomized trials using the PAM50 risk of recurrence score. J Clin Oncol. 2015 Mar 10;33(8):916-22. doi: 10.1200/JCO.2014.55.6894. Epub 2014 Oct 20.
- Derived from this study: PubMed 24347518Gnant M, Filipits M, Greil R, Stoeger H, Rudas M, Bago-Horvath Z, Mlineritsch B, Kwasny W, Knauer M, Singer C, Jakesz R, Dubsky P, Fitzal F, Bartsch R, Steger G, Balic M, Ressler S, Cowens JW, Storhoff J, Ferree S, Schaper C, Liu S, Fesl C, Nielsen TO; Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014 Feb;25(2):339-45. doi: 10.1093/annonc/mdt494. Epub 2013 Dec 16.
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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.
Raimund Jakesz, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
AstraZeneca Austria Medical Director, MD study director
AstraZeneca
52 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 Tamoxifen and Anastrozole in people with Breast Cancer, run by AstraZeneca at 52 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 5 inclusion and 6 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 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 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?
To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.. 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 NCT00291759, 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 30 Jan 2013.