Breast CancerPhase 3NCT00286117
ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years
A Phase 3 study testing Anastrozole and Tamoxifen in people with Breast Cancer, run by AstraZeneca at 25 sites in Italy.
Trial summary
The purpose of this study was 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 on tamoxifen. 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
- 448 participants
- Where
- 25 sitesItaly
- Study dates
- Mar 1998to May 2006
- 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 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-menopausal status; age ≤75 years;
- histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes;
- oestrogen receptor status positive or unknown;
- primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed
Who cannot join
- Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Italy25 sites
Research Site
Arezzo
Research Site
Bologna
Research Site
Casalpusterlengo
Research Site
Catania
Research Site
Chieti
Research Site
Ferrara
Research Site
Florence
Research Site
Forlì
Research Site
Genova
Research Site
Lugo
Research Site
Messina
Research Site
Milan
Research Site
Monserrato
Research Site
Palermo
Research Site
Pavia
Research Site
Pinerolo
Research Site
Roma
Research Site
Rovigo
Research Site
Sanremo
Research Site
Saronno
Research Site
Sassari
Research Site
Terni
Research Site
Torino
Research Site
Trieste
Research Site
Vicenza
About this study
Official title: An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years
The purpose of this study was 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 on tamoxifen.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole, Tamoxifen
- 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.
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.
The primary objective of this analysis was 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 on tamoxifen
Secondary outcomes (1)
Assess the difference in overall survival/disease recurrence/safety and tolerability between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startMar 1998
- Study completionMay 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Cancer Research, United Kingdom
- Investigators
- AstraZeneca Arimidex Medical Science Director, MD, Study director, AstraZenecaFrancesco Boccardo, MD, Principal investigator, University and National Cancer Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286117
- Sponsor's protocol ID
- 1033IT/0002
- Other IDs
- ITA
- Status last verified
- Apr 2009
- First submitted
- 2 Feb 2006
- Last updated
- 1 May 2009
- Results posted
- No
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
- An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years
- ClinicalTrials.gov ID
- NCT00286117
- Acronym / sponsor ID
- 1033IT/0002
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- Mar 1998
- Study completion
- May 2006 (actual)
- First posted
- 3 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 was 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 on tamoxifen.
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 (4 listed)
- Post-menopausal status; age ≤75 years;
- histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes;
- oestrogen receptor status positive or unknown;
- primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed
Key exclusion criteria (1 listed)
- Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).
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
The primary objective of this analysis was 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 on tamoxifen
1 secondary outcome
Assess the difference in overall survival/disease recurrence/safety and tolerability between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.
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.
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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 Arimidex Medical Science Director, MD study director
AstraZeneca
Francesco Boccardo, MD principal investigator
University and National Cancer Research Institute
25 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 and Tamoxifen in people with Breast Cancer, run by AstraZeneca at 25 sites in Italy.
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 4 inclusion and 1 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 25 sites in Italy. 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?
The primary objective of this analysis was 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 on 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 1 May 2009.