PROACT - Pre-Operative Arimidex Compared To Tamoxifen

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: ARIMIDEX (anastrazole)

Drug: NOLVADEX (tamoxifen)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00232661

1033IL/0039

D5395C00039

Details and patient eligibility

About

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.

Enrollment

452 patients

Sex

Female

Ages

60+ years old

Volunteers

No Healthy Volunteers

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