PROACT - Pre-Operative Arimidex Compared To Tamoxifen

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00232661
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2003-01
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-05
• Study Completion: 2007-12
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 452

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective tumour response	Assessed at 3 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life assessments	Assessed at 3 months
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
Complications due to surgery	Assessed up to 30 days post-surgery
Health economics outcomes	Assessed up to 30 days post-surgery
Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate	Assessed up to 5 years + 30 days
Recurrence-free survival and survival	Assessed up to 5 years

Trial Locations

Locations (1)

Research Site; 🇳🇱 Sittard, Netherlands