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.
Phase 3
60 Years
N/A
60 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Objective tumour response
Outcome Time Frame:
Assessed at 3 months
Safety Issue:
No
Principal Investigator
AstraZeneca Arimidex Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
1033IL/0039
NCT ID:
NCT00232661
Start Date:
August 2000
Completion Date:
December 2007
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Danbury, Connecticut |
| Research Site | Arlington Heights, Illinois |
| Research Site | Ames, Iowa |
| Research Site | Baton Rouge, Louisiana |
| Research Site | Beverly, Massachusetts |
| Research Site | Branson, Missouri |
| Research Site | Albuquerque, New Mexico |
| Research Site | Bend, Oregon |
| Research Site | Abilene, Texas |
| Research Site | Auburn, Washington |
