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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
ISRCTN ISRCTN18233230
DOI 10.1186/ISRCTN18233230
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym ATAC (Arimidex, Tamoxifen, Alone or in Combination)
Serial number at source ZEN1033IL/29
Study hypothesis Not provided at time of registration
Lay summary http://cancerhelp.cancerresearchuk.org/trials/a-trial-comparing-anastrozole-and-tamoxifen-after-surgery-for-breast-cancer
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Breast cancer
Participants - 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
Participants - exclusion criteria Does not match inclusion criteria
Anticipated start date 01/01/1998
Anticipated end date 01/12/1999
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Not provided at time of registration
Interventions 1. Group A: Arimidex (anstrozole) 1 mg plus Nolvadex (tamoxifen) placebo both daily for 5 years or until recurrence
2. Group B: Arimidex 1 mg plus Nolvadex 20 mg, both daily for 5 years or until recurrence
3. Group C: Arimidex placebo plus Nolvadex 20 mg, both daily for 5 years or until recurrence
Primary outcome measure(s) Not provided at time of registration
Secondary outcome measure(s) Not provided at time of registration
Sources of funding AstraZeneca Pharmaceuticals (UK)
Trial website
Publications 1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15639680
2. 2007 results of long-term safety analysis in http://www.ncbi.nlm.nih.gov/pubmed/16887480
3. 2008 results of 100-month analysis in http://www.ncbi.nlm.nih.gov/pubmed/18083636
4. 2008 five year results in http://www.ncbi.nlm.nih.gov/pubmed/18309940
5. 2010 results on the effect of body mass index on recurrence rates in http://www.ncbi.nlm.nih.gov/pubmed/20547990
6. 2010 results on 10 year analysis of trial in http://www.ncbi.nlm.nih.gov/pubmed/18233230
7. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22475046
Contact name Ms  Joan  Houghton
  Address ATAC secretariat
c/o Charles Bell House
67-73 Riding House Street
  City/town London
  Zip/Postcode W1W 7EJ
  Country United Kingdom
  Email j.houghton@ctg.ucl.ac.uk
Sponsor AstraZeneca Clinical Research Group (UK)
  Address 10 Logie Mill
Beaverbank Office Park
Lovie Green Road
  City/town Edinburgh
  Zip/Postcode EH7 4HG
  Country United Kingdom
  Sponsor website: http://www.astrazeneca.co.uk
Date applied 19/08/2002
Last edited 07/05/2013
Date ISRCTN assigned 19/08/2002
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