Skip to content

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 Women

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 Women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74551156
Enrollment
Unknown
Registered
2002-08-19
Start date
1996-01-01
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Breast

Interventions

1. Group A: Arimidex (anastrozole) 1 mg plus tamoxifen placebo daily 2. Group B: Tamoxifen 20 mg plus Arimidex placebo daily

Sponsors

AstraZeneca Clinical Research Group (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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 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

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026