A randomised double-blind trial comparing arimidex alone with nolvadex alone with arimidex and nolvadex in combination, as adjuvant treatment in post-menopausal women with breast cancer

Not Applicable

Completed

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN18233230
• Lead Sponsor: AstraZeneca Clinical Research Group (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08-19
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 0

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 <60 years with a uterus and amenorrhoea for at least 12 months
3.4. Aged <60 without a uterus and with follicle stimulating hormone (FSH) >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

Does not match inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified