PROACT - Pre-Operative Arimidex Compared To Tamoxifen

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00232661

Run by

AstraZeneca

People needed

452

Starts

2000-08-01

Expected to finish

2007-12-01

Last updated by the study team

2010-02-03

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Research Site — New Britain, Connecticut, United States
• Research Site — Torrington, Connecticut, United States
• Research Site — Springfield, Illinois, United States
• Research Site — Mason City, Iowa, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Pittsfield, Massachusetts, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Portland, Oregon, United States
• Research Site — Austin, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Olympia, Washington, United States
• Research Site — Antwerp, Belgium
• Research Site — Hasselt, Belgium
• Research Site — Leuven, Belgium
• Research Site — Liège, Belgium
• Research Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Research Site — Porto Alegre, Rio Grande do Sul, Brazil
• Research Site — São Paulo, São Paulo, Brazil
• Research Site — Fortaleza, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Sheffield, Brazil
• Research Site — Edmonton, Alberta, Canada
• Research Site — Newmarket, Ontario, Canada
• Research Site — Santa Rosa, California, United States

Full record on ClinicalTrials.gov

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