PROACT - Pre-Operative Arimidex Compared To Tamoxifen

NCT ID: NCT00232661

Last Updated: 2010-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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ARIMIDEX (anastrazole)

Intervention Type DRUG

NOLVADEX (tamoxifen)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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AstraZeneca Arimidex Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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United States Belgium Brazil Canada Czechia France Hungary Italy Japan Netherlands

References

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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.

Reference Type RESULT
PMID: 16598749 (View on PubMed)

Fujiwara 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.

Reference Type DERIVED
PMID: 22136317 (View on PubMed)

Other Identifiers

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D5395C00039

Identifier Type: -

Identifier Source: secondary_id

1033IL/0039

Identifier Type: -

Identifier Source: org_study_id

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