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ISRCTN
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ISRCTN74551156
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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ZEN1033IL/27
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised Double-Blind, Double Dummy Trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1996
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Anticipated end date
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01/07/1998
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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1. Group A: Arimidex (anastrozole) 1 mg plus tamoxifen placebo daily
2. Group B: Tamoxifen 20 mg plus Arimidex placebo daily
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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AstraZeneca Pharmaceuticals (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Sponsor
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AstraZeneca Clinical Research Group (UK)
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Address
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10 Logie Mill
Beaverbank Office Park
Lovie Green Road
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City/town
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Edinburgh
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Zip/Postcode
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EH7 4HG
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Country
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United Kingdom
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Tel
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+44(0)1316523000
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Fax
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+44(0)1315574858
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Email
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Sponsor website:
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http://www.astrazeneca.co.uk
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Date applied
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19/08/2002
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Last edited
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29/05/2008
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Date ISRCTN assigned
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19/08/2002
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