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ISRCTN
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ISRCTN99515843
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ClinicalTrials.gov identifier
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Public title
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A Randomised Trial of Sequential Aromatase Inhibitors (AI) in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer. The SAINT Trial
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Scientific title
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Acronym
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SAINT
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Serial number at source
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C/15/00
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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 controlled 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
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Participants - inclusion criteria
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1. Patients with positive estrogen receptor (ER) and/or progesterone receptor (PgR) status
2. Postmenopausal
3. Measurable or accessible locally advanced, unresectable or locoregionally recurrent or metastatic breast carcinoma with documented disease progression
4. At least one bidimensionally measurable lesion should be available for assessment
5. Patients would have failed to respond to previous first line treatment with anti-oestrogens
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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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01/01/2001
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Anticipated end date
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31/12/2004
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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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In the experimental arms of the study (A1 and A2) patients will initially receive a second generation AI (in the form of Formestane, 250 mg im 2-weekly) followed at disease progression by a third generation AI, which by randomisation will be either (A1) non steroidal (Anastrazole 1 mg po daily) or (A2) steroidal (Exemestane 25 mg po daily).
Patients in the control arms of the study (B1 and B2) will receive immediate Anastrazole 1 mg po daily (B1) or Exemestane 25 mg po daily (B2).
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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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International Collaborative Cancer Group (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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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International Collaborative Cancer Group (ICGG) (UK)
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Address
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Medical Oncology
Charing Cross Hospital
Fulham Palace Road
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City/town
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London
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Zip/Postcode
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W6 8RF
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Country
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United Kingdom
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Date applied
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19/08/2002
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Last edited
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14/05/2008
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Date ISRCTN assigned
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19/08/2002
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