Breast CancerPhase 3NCT00232661
PROACT - Pre-Operative Arimidex Compared To Tamoxifen
A Phase 3 study testing ARIMIDEX (anastrazole) and NOLVADEX (tamoxifen) in people with Breast Cancer, run by AstraZeneca at 79 sites in 10 countries.
Trial summary
The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ARIMIDEX (anastrazole) and NOLVADEX (tamoxifen)
- How many people
- 452 participants
- Where
- 79 sitesin 10 countries
- Study dates
- Aug 2000to Dec 2007
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operable or potentially operable breast cancer
- Invasive breast cancer proven to be hormone-sensitive (ER+/PR+)
- Patients who might benefit from endocrine treatment prior to surgery
- Postmenopausal
- Signed written informed consent
Who cannot join
- Inoperable breast cancer
- Patient unwilling to undergo surgery
- Any reason why the patient may not be able to conform to study requirements
- Any previous treatment for breast cancer
- Previous Tamoxifen use as a part of breast cancer prevention trials
- Not willing to stop taking drugs that affect sex-hormones such as HRT
Show all 11Show fewer
- Previous history of breast cancer
- Previous history of invasive malignancy within the last 10 years
- Any other severe disease that may prevent surgery, place the patient at risk, or influence the study results
- Treatment with an experimental drug within the last 3 months
- Risk of transmitting HIV, Hepatitis B or C
Trial locations and contacts
79 sites in 10 countries.
79 sites in 10 countries
Japan19 sites
Research Site
Amagasaki, Hyōgo
Research Site
Chiba, Chiba
Research Site
Chūō, Tokyo
Research Site
Fukuoka, Fukuoka
Research Site
Fukuyama, Hiroshima
Research Site
Isehara, Kanagawa
Research Site
Kitaadachi, Saitama
Research Site
Kitakyushu, Fukuoka
Research Site
Kumamoto, Kumamoto
Research Site
Matsuyama, Ehime
Research Site
Nagoya, Aichi-ken
Research Site
Niigata, Niigata
Research Site
Ōita, Oita Prefecture
Research Site
Osaka, Osaka
Research Site
Ōta, Gunma
Research Site
Sapporo, Hokkaido
Research Site
Sayama, Osaka
Research Site
Suita, Osaka
Research Site
Yokohama, Kanagawa
United States13 sites
Research Site
Albuquerque, New Mexico
Research Site
Austin, Texas
Research Site
Baton Rouge, Louisiana
Research Site
Houston, Texas
Research Site
Mason City, Iowa
Research Site
New Britain, Connecticut
Research Site
Olympia, Washington
Research Site
Pittsfield, Massachusetts
Research Site
Portland, Oregon
Research Site
Santa Rosa, California
Research Site
Springfield, Illinois
Research Site
St Louis, Missouri
Research Site
Torrington, Connecticut
France10 sites
Research Site
Avignon
Research Site
Dijon
Research Site
Limoges
Research Site
Lyon, Cedex 08
Research Site
Lyon
Research Site
Marseille
Research Site
Montpellier
Research Site
Nice
Research Site
Paris
Research Site
Tours
Italy8 sites
Research Site
Bologna, BO
Research Site
Cagliari, CA
Research Site
Florence, FI
Research Site
Genova, GE
Research Site
Kashiwa, Chiba
Research Site
Monserrato, CA
Research Site
Palermo, PA
Research Site
Reggio Emilia, RE
Brazil6 sites
Research Site
Fortaleza
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
Porto Alegre
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
São Paulo, São Paulo
Research Site
Sheffield
Czechia6 sites
Research Site
Brno
Research Site
Nová Ves pod Pleší
Research Site
Olomouc
Research Site
Peské Budjovice
Research Site
Prague
Research Site
Praha-5
Canada5 sites
Research Site
Chicoutimi, Quebec
Research Site
Edmonton, Alberta
Research Site
Montreal, Quebec
Research Site
Newmarket, Ontario
Research Site
Québec, Quebec
Hungary5 sites
Research Site
Budapest
Research Site
Győr
Research Site
Kecskemét
Research Site
Szeged
Research Site
Szolnok
Belgium4 sites
Research Site
Antwerp
Research Site
Hasselt
Research Site
Leuven
Research Site
Liège
Netherlands3 sites
Research Site
Nijmegen
Research Site
Sittard
Research Site
The Hague
About this study
Official title: A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Breast Cancer.
The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.
- Conditions
- Breast Cancer
- Being tested
- ARIMIDEX (anastrazole), NOLVADEX (tamoxifen)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARIMIDEX (anastrazole)Drug
NOLVADEX (tamoxifen)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumour response
Measured: Assessed at 3 months
Secondary outcomes (10)
Pathological response
Measured: Assessed at 3 months
Extent of breast surgery
Measured: Assessed at 3 months
Extent of axillary down-staging
Measured: Assessed at 3 months
Clinical ultrasound response versus clinical caliper response
Measured: Assessed at 3 months
Safety
Measured: Assessed up to 5 years + 30 days
Complications due to surgery
Measured: Assessed up to 30 days post-surgery
Health economics outcomes
Measured: Assessed up to 30 days post-surgery
Quality of Life assessments
Measured: Assessed at 3 months
Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate
Measured: Assessed up to 5 years + 30 days
Recurrence-free survival and survival
Measured: Assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startAug 2000
- Primary completionJan 2003
- Study completionDec 2007
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Arimidex Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232661
- Sponsor's protocol ID
- 1033IL/0039
- Other IDs
- D5395C00039
- Status last verified
- Feb 2010
- First submitted
- 30 Sep 2005
- Last updated
- 3 Feb 2010
- Results posted
- No
Publications
Cataliotti L, Buzdar AU, Noguchi S, Bines J, Takatsuka Y, Petrakova K, Dube P, de Oliveira CT. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) trial. Cancer. 2006 May 15;106(10):2095-103. doi: 10.1002/cncr.21872.
PubMed 16598749Fujiwara Y, Takatsuka Y, Imoto S, Inaji H, Ikeda T, Akiyama F, Tamura M, Miyoshi K, Iwata H, Mitsuyama S, Noguchi S. Outcomes of Japanese breast cancer patients treated with pre-operative and post-operative anastrozole or tamoxifen. Cancer Sci. 2012 Mar;103(3):491-6. doi: 10.1111/j.1349-7006.2011.02171.x. Epub 2012 Jan 13.
PubMed 22136317
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Breast Cancer.
- ClinicalTrials.gov ID
- NCT00232661
- Acronym / sponsor ID
- 1033IL/0039
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Jan 2003 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Oct 2005 (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 compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Operable or potentially operable breast cancer
- Invasive breast cancer proven to be hormone-sensitive (ER+/PR+)
- Patients who might benefit from endocrine treatment prior to surgery
- Postmenopausal
- Signed written informed consent
Key exclusion criteria (11 listed)
- Inoperable breast cancer
- Patient unwilling to undergo surgery
- Any reason why the patient may not be able to conform to study requirements
- Any previous treatment for breast cancer
- Previous Tamoxifen use as a part of breast cancer prevention trials
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 |
|---|---|---|
| ARIMIDEX (anastrazole) | Drug | – |
| NOLVADEX (tamoxifen) | Drug | – |
Primary outcome
Objective tumour response
Time frame: Assessed at 3 months
10 secondary outcomes
Pathological response
Time frame: Assessed at 3 months
Extent of breast surgery
Time frame: Assessed at 3 months
Extent of axillary down-staging
Time frame: Assessed at 3 months
Clinical ultrasound response versus clinical caliper response
Time frame: Assessed at 3 months
Safety
Time frame: Assessed up to 5 years + 30 days
Complications due to surgery
Time frame: Assessed up to 30 days post-surgery
Health economics outcomes
Time frame: Assessed up to 30 days post-surgery
Quality of Life assessments
Time frame: Assessed at 3 months
Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate
Time frame: Assessed up to 5 years + 30 days
Recurrence-free survival and survival
Time frame: Assessed up to 5 years
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 3 Feb 2010.
- Results publication: PubMed 16598749Cataliotti L, Buzdar AU, Noguchi S, Bines J, Takatsuka Y, Petrakova K, Dube P, de Oliveira CT. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) trial. Cancer. 2006 May 15;106(10):2095-103. doi: 10.1002/cncr.21872.
- Derived from this study: PubMed 22136317Fujiwara Y, Takatsuka Y, Imoto S, Inaji H, Ikeda T, Akiyama F, Tamura M, Miyoshi K, Iwata H, Mitsuyama S, Noguchi S. Outcomes of Japanese breast cancer patients treated with pre-operative and post-operative anastrozole or tamoxifen. Cancer Sci. 2012 Mar;103(3):491-6. doi: 10.1111/j.1349-7006.2011.02171.x. Epub 2012 Jan 13.
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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
79 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARIMIDEX (anastrazole) and NOLVADEX (tamoxifen) in people with Breast Cancer, run by AstraZeneca at 79 sites in 10 countries.
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 11 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 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Japan, United States, France, Italy, Brazil and 5 more countries. 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?
Objective tumour response (time frame: Assessed at 3 months). 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 NCT00232661, 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 3 Feb 2010.