A Randomised Double-Blind, Double Dummy Trial to Compare the Efficacy and Safety of Arimidex with Tamoxifen as First line Therapy for Advanced Breast Cancer in Post-Menopausal Wome

Not Applicable

Completed

• Conditions: Breast cancer; Cancer; Breast

• Registration Number: ISRCTN74551156
• Lead Sponsor: AstraZeneca Clinical Research Group (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 1998-07-01
• Study Start: 2002-08-19
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients with locally advanced or metastatic breast cancer who are candidates to receive hormonal therapy as first line therapy for advanced disease (patients may have received adjuvant chemotherapy or hormonal therapy but patients who have received tamoxifen as adjuvant therapy must have an interval of at least 12 months since stopping tamoxifen and entry into this trial)
2. Post-menopausal defined as:
2.1 Aged >50 years or who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone (FSH) levels within the post-menopausal range
2.2 Women aged <50 years who have FSH levels within the post-menopausal range
3. Hormone receptor (oestrogen receptor and or progesterone receptor) positive or unknown
4. Measurable or evaluable disease
5. No previous systemic therapy for advanced breast cancer
6. No drug-maintained menopausal status
7. No evidence of life threatening visceral disease
8. Life expectancy of >3 months
9. No treatment with a non-approved or experimental drug within the preceding 3 months before randomisation
10. No prior history of other malignancy other than breast cancer, except basal cell or squamous cell carcinoma of the skin or cancer of the cervix which has been satisfactorily controlled
11. No contraindications to protocol treatments

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration