Breast CancerPhase 2ARNO-95NCT00287534
Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
A Phase 2 study testing Anastrozole and Tamoxifen in people with Breast Cancer, run by AstraZeneca at 43 sites in Germany.
Trial summary
The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole and Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,059 participants
- Where
- 43 sitesGermany
- Study dates
- Nov 1996to Sep 2004
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent,
- Post-menopausal women ≤75 years,
- histologically confirmed invasive breast carcinoma (no distant metastases),
- positive hormone receptor status,
- continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery
Who cannot join
- menopause status maintained by medication,
- pre-operative chemotherapy or hormone therapy or radiation therapy,
- relapse or second carcinoma or previous cancerous disease,
- breast carcinoma in situ,
- simultaneous carcinoma of the opposite side or secondary breast,
- 10 or more tumour-infiltrated lymph nodes.
- serious accompanying diseases
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Germany43 sites
Research Site
Albstadt
Research Site
Berlin
Research Site
Cloppenburg
Research Site
Eggenfelden
Research Site
Frankfurt
Research Site
Freiburg im Breisgau
Research Site
Göttingen
Research Site
Halle
Research Site
Hamburg
Research Site
Hanau
Research Site
Hanover
Research Site
Heidelberg
Research Site
Hoyerswerda
Research Site
Idar-Oberstein
Research Site
Jena
Research Site
Karlsruhe
Research Site
Kassel
Research Site
Kiel
Research Site
Leonberg
Research Site
Lingen
Research Site
Lübeck
Research Site
Magdeburg
Research Site
Mainz
Research Site
Mannheim
Research Site
München
Research Site
Münster
Research Site
Neustadt
Research Site
Osnabrück
Research Site
Paderborn
Research Site
Pforzheim
Research Site
Recklinghausen
Research Site
Rosenheim
Research Site
Rostock
Research Site
Rüsselsheim am Main
Research Site
Schleswig
Research Site
Siegen
Research Site
Titisee-Neustadt
Research Site
Tübingen
Research Site
Ulm
Research Site
Waiblingen
Research Site
Westerstede
Research Site
Worms
Research Site
Würzburg
About this study
Official title: A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer
- Conditions
- Breast Cancer
- Being tested
- Anastrozole, Tamoxifen
- Keywords
- Early 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
Also called Arimidex, ZD1033
oral
TamoxifenDrug
Also called Nolvadex
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Anastrozole Receives: Drug: Anastrozole |
| 2 | Active comparator | Tamoxifen Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen
Secondary outcomes (3)
To assess difference in overall survival between the two treatment arms
To assess difference in disease recurrence between the two treatment arms
To assess difference in safety and tolerability between the two treatment arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startNov 1996
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,059 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German Adjuvant Breast Cancer Group
- Investigators
- Manfred Kaufmann, MD, Principal investigator, German Adjuvant Breast Cancer Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287534
- Sponsor's protocol ID
- 1033GR/0001
- Other IDs
- ARNO-95
- Acronym
- ARNO-95
- Status last verified
- Jun 2009
- First submitted
- 6 Feb 2006
- Last updated
- 9 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT00287534
- Acronym / sponsor ID
- ARNO-95 / 1033GR/0001
- Conditions
- Breast Cancer
- Keywords
- Early Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,059 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- German Adjuvant Breast Cancer Group
- Study start
- Nov 1996
- Study completion
- Sep 2004 (actual)
- First posted
- 7 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 determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AnastrozoleAnastrozole |
| 2 | Active comparator | Drug: TamoxifenTamoxifen |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent,
- Post-menopausal women ≤75 years,
- histologically confirmed invasive breast carcinoma (no distant metastases),
- positive hormone receptor status,
- continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery
Key exclusion criteria (7 listed)
- menopause status maintained by medication,
- pre-operative chemotherapy or hormone therapy or radiation therapy,
- relapse or second carcinoma or previous cancerous disease,
- breast carcinoma in situ,
- simultaneous carcinoma of the opposite side or secondary breast,
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 |
|---|---|---|
| AnastrozoleAlso: Arimidex, ZD1033oral | Drug | 1 |
| TamoxifenAlso: Nolvadexoral | Drug | 2 |
Primary outcome
To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen
3 secondary outcomes
To assess difference in overall survival between the two treatment arms
To assess difference in disease recurrence between the two treatment arms
To assess difference in safety and tolerability between the two treatment arms
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 9 Jun 2009.
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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.
Manfred Kaufmann, MD principal investigator
German Adjuvant Breast Cancer Group
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anastrozole and Tamoxifen in people with Breast Cancer, run by AstraZeneca at 43 sites in Germany.
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 7 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 9 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Germany. 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?
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 disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2009.