Breast cancer Cancer Breast cancer
Conditions
Interventions
1. Group A: Arimidex (anstrozole) 1 mg plus Nolvadex (tamoxifen) placebo both daily for 5 years or until recurrence
2. Group B: Arimidex 1 mg plus Nolvadex 20 mg, both daily for 5 years or until recur
Sponsors
AstraZeneca Clinical Research Group (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically proven operable breast cancer 2. Patients must have completed primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy 3. Deemed to be post-menopausal according to one of the following: 3.1. Aged >60 years 3.2. Bilateral oophorectomy 3.3. Aged 20IU/L 4. No evidence of metastatic disease 5. If chemotherapy was started more than 8 weeks after primary surgery or chemotherapy was completed more than 8 weeks before randomisation the patients is excluded 6. No neo-adjuvant chemotherapy 7. Surgery must have been completed within 8 weeks prior to randomisation 8. No previous hormonal therapy as adjuvant treatment for breast cancer unless: 8.1. Tamoxifen received prior to first surgical procedure for 28 days or less 8.2. Hormonal therapy received pre-surgery in the context of a formal trial 9. Patients who have received tamoxifen as part of any breast cancer prevention trial are to be excluded 10. No previous malignancy within the last 10 years, except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied 11. No treatment with a non-approved drug during the 3 months before randomisation 12. No medical contraindications to any of the treatments in the trial
Exclusion criteria
Exclusion criteria: Does not match inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed