Breast CancerPhase 3NCT00849030
ATAC - Arimidex, Tamoxifen Alone or in Combination
A Phase 3 study testing Anastozole (Arimidex) and Tamoxifen (Nolvadex) in people with Breast Cancer, run by AstraZeneca.
Trial summary
The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastozole (Arimidex) and Tamoxifen (Nolvadex)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,358 participants
- Where
- No sites listed yet
- Study dates
- Jul 1996to Apr 2010
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven operable invasive breast cancer
- Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
- Women defined as post-menopausal
Who cannot join
- Patients in whom there is any clinical evidence of metastatic disease
- Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
- Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
About this study
Official title: A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer
The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Anastozole (Arimidex), Tamoxifen (Nolvadex), Anastozole (Arimidex) placebo, Tamoxifen (Nolvadex) placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastozole (Arimidex)Drug
Also called Arimidex
1mg, orally, once daily
Tamoxifen (Nolvadex)Drug
Also called Nolvadex
20mg, orally, once daily
Anastozole (Arimidex) placeboDrug
1mg, orally, once daily
Tamoxifen (Nolvadex) placeboDrug
20mg, orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Arimidex 1mg + Nolvadex placebo Receives: Drug: Anastozole (Arimidex); Drug: Tamoxifen (Nolvadex) placebo |
| 2 | Active comparator | Arimidex placebo + Nolvadex 20mg Receives: Drug: Tamoxifen (Nolvadex); Drug: Anastozole (Arimidex) placebo |
| 3 | Active comparator | Arimidex 1mg + Nolvadex 20mg Receives: Drug: Anastozole (Arimidex); Drug: Tamoxifen (Nolvadex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence of breast cancer
Measured: Earliest of local or distant recurrence, new primary breast cancer, or death
Safety and side effects
Measured: Earliest of local or distant recurrence, new primary breast cancer, or death
Secondary outcomes (3)
Time to distant recurrence
Measured: Earliest of local or distant recurrence, new primary breast cancer, or death
Survival
Measured: Earliest of local or distant recurrence, new primary breast cancer, or death
New breast primaries
Measured: Earliest of local or distant recurrence, new primary breast cancer, or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startJul 1996
- Primary completionJun 2001
- Study completionApr 2010
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9,358 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849030
- Sponsor's protocol ID
- 1033IL/0029
- Other IDs
- D5392C00029
- Status last verified
- Jun 2012
- First submitted
- 20 Feb 2009
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00849030
- Acronym / sponsor ID
- 1033IL/0029
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,358 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 1996
- Primary completion
- Jun 2001 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Feb 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.
The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Anastozole (Arimidex), Drug: Tamoxifen (Nolvadex) placeboArimidex 1mg + Nolvadex placebo |
| 2 | Active comparator | Drug: Tamoxifen (Nolvadex), Drug: Anastozole (Arimidex) placeboArimidex placebo + Nolvadex 20mg |
| 3 | Active comparator | Drug: Anastozole (Arimidex), Drug: Tamoxifen (Nolvadex)Arimidex 1mg + Nolvadex 20mg |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histologically proven operable invasive breast cancer
- Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
- Women defined as post-menopausal
Key exclusion criteria (3 listed)
- Patients in whom there is any clinical evidence of metastatic disease
- Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
- Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
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 |
|---|---|---|
| Anastozole (Arimidex)Also: Arimidex1mg, orally, once daily | Drug | 1, 3 |
| Tamoxifen (Nolvadex)Also: Nolvadex20mg, orally, once daily | Drug | 2, 3 |
| Anastozole (Arimidex) placebo1mg, orally, once daily | Drug | 2 |
| Tamoxifen (Nolvadex) placebo20mg, orally, once daily | Drug | 1 |
Primary outcome
Time to recurrence of breast cancer
Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death
Safety and side effects
Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death
3 secondary outcomes
Time to distant recurrence
Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death
Survival
Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death
New breast primaries
Time frame: Earliest of local or distant recurrence, new primary breast cancer, or death
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 6 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anastozole (Arimidex) and Tamoxifen (Nolvadex) in people with Breast Cancer, run by AstraZeneca.
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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Time to recurrence of breast cancer (time frame: Earliest of local or distant recurrence, new primary breast cancer, or death). The study lists 2 primary outcomes in all. 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 6 Jun 2012.