Breast Cancer
Conditions
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.
Interventions
DRUGARIMIDEX (anastrazole)
DRUGNOLVADEX (tamoxifen)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumour response | Assessed at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Pathological response | Assessed at 3 months |
| 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 |
| Complications due to surgery | Assessed up to 30 days post-surgery |
Countries
Belgium, Brazil, Canada, Czechia, France, Hungary, Italy, Japan, Netherlands, United States
Outcome results
None listed