Status:
COMPLETED
PROACT - Pre-Operative Arimidex Compared To Tamoxifen
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
60+ years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT00232661
Start Date
August 1 2000
End Date
December 1 2007
Last Update
February 3 2010
Active Locations (79)
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1
Research Site
Santa Rosa, California, United States
2
Research Site
New Britain, Connecticut, United States
3
Research Site
Torrington, Connecticut, United States
4
Research Site
Springfield, Illinois, United States