PROACT - Pre-Operative Arimidex Compared To Tamoxifen
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.
2 other identifiers
interventional
452
10 countries
79
Brief 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 surgery that is required.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Aug 2000
Typical duration for phase_3 breast-cancer
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 3, 2010
February 1, 2010
2.4 years
September 30, 2005
February 2, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Objective tumour response
Assessed at 3 months
Secondary Outcomes (10)
Pathological response
Assessed at 3 months
Extent of breast surgery
Assessed at 3 months
Extent of axillary down-staging
Assessed at 3 months
Clinical ultrasound response versus clinical caliper response
Assessed at 3 months
Safety
Assessed up to 5 years + 30 days
- +5 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (79)
Research Site
Santa Rosa, California, United States
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New Britain, Connecticut, United States
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Torrington, Connecticut, United States
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Springfield, Illinois, United States
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Mason City, Iowa, United States
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Baton Rouge, Louisiana, United States
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Pittsfield, Massachusetts, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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Portland, Oregon, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Olympia, Washington, United States
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Antwerp, Belgium
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Hasselt, Belgium
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Leuven, Belgium
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Liège, Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Fortaleza, Brazil
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Porto Alegre, Brazil
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Sheffield, Brazil
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Edmonton, Alberta, Canada
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Newmarket, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Brno, Czechia
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Nová Ves pod Pleší, Czechia
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Olomouc, Czechia
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Peské Budjovice, Czechia
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Prague, Czechia
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Praha-5, Czechia
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Lyon, Cedex 08, France
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Avignon, France
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Dijon, France
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Limoges, France
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Lyon, France
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Marseille, France
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Montpellier, France
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Nice, France
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Paris, France
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Tours, France
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Budapest, Hungary
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Győr, Hungary
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Kecskemét, Hungary
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Szeged, Hungary
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Szolnok, Hungary
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Bologna, BO, Italy
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Cagliari, CA, Italy
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Monserrato, CA, Italy
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Kashiwa, Chiba, Italy
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Florence, FI, Italy
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Genova, GE, Italy
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Palermo, PA, Italy
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Reggio Emilia, RE, Italy
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Nagoya, Aichi-ken, Japan
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Chiba, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Ōta, Gunma, Japan
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Fukuyama, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Amagasaki, Hyōgo, Japan
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Isehara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Niigata, Niigata, Japan
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Ōita, Oita Prefecture, Japan
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Osaka, Osaka, Japan
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Sayama, Osaka, Japan
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Suita, Osaka, Japan
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Kitaadachi, Saitama, Japan
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Chūō, Tokyo, Japan
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Nijmegen, Netherlands
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Sittard, Netherlands
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The Hague, Netherlands
Related Publications (2)
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.
PMID: 16598749RESULTFujiwara 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.
PMID: 22136317DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Arimidex Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 5, 2005
Study Start
August 1, 2000
Primary Completion
January 1, 2003
Study Completion
December 1, 2007
Last Updated
February 3, 2010
Record last verified: 2010-02