PROACT - Pre-Operative Arimidex Compared To Tamoxifen

Study Overview
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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.

Official Title
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A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Breast Cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: ARIMIDEX (anastrazole)
* Drug: NOLVADEX (tamoxifen)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARIMIDEX (anastrazole)|nan|
|Drug: NOLVADEX (tamoxifen)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumour response |  | Assessed at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Quality of Life assessments |  | Assessed at 3 months | 
| 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 |