Breast Cancer
Conditions
Brief summary
The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.
Interventions
DRUGAnastozole (Arimidex)
1mg, orally, once daily
20mg, orally, once daily
DRUGAnastozole (Arimidex) placebo
1mg, orally, once daily
20mg, orally, once daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically proven operable invasive breast cancer * Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy * Women defined as post-menopausal
Exclusion criteria
* Patients in whom there is any clinical evidence of metastatic disease * Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements * Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recurrence of breast cancer | Earliest of local or distant recurrence, new primary breast cancer, or death |
| Safety and side effects | Earliest of local or distant recurrence, new primary breast cancer, or death |
Secondary
| Measure | Time frame |
|---|---|
| Time to distant recurrence | Earliest of local or distant recurrence, new primary breast cancer, or death |
| Survival | Earliest of local or distant recurrence, new primary breast cancer, or death |
| New breast primaries | Earliest of local or distant recurrence, new primary breast cancer, or death |
Outcome results
None listed