Official Title: “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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: ARIMIDEX (anastrazole)
• Drug: NOLVADEX (tamoxifen)

Primary Measures

• Objective tumour response
  • Time Frame: Assessed at 3 months
    Safety Issue?: No

Secondary Measures

• Pathological response
  • Time Frame: Assessed at 3 months
    Safety Issue?: No
• Extent of breast surgery
  • Time Frame: Assessed at 3 months
    Safety Issue?: No
• Extent of axillary down-staging
  • Time Frame: Assessed at 3 months
    Safety Issue?: No
• Clinical ultrasound response versus clinical caliper response
  • Time Frame: Assessed at 3 months
    Safety Issue?: No
• Safety
  • Time Frame: Assessed up to 5 years + 30 days
    Safety Issue?: No
• Complications due to surgery
  • Time Frame: Assessed up to 30 days post-surgery
    Safety Issue?: No
• Health economics outcomes
  • Time Frame: Assessed up to 30 days post-surgery
    Safety Issue?: No
• Quality of Life assessments
  • Time Frame: Assessed at 3 months
    Safety Issue?: No
• Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate
  • Time Frame: Assessed up to 5 years + 30 days
    Safety Issue?: No
• Recurrence-free survival and survival
  • Time Frame: Assessed up to 5 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Arimidex Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00232661

Study ID Number: 1033IL/0039 (D5395C00039)

ClinicalTrials.gov Identifier: NCT00232661

Health Authority: United States: Food and Drug Administration