Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Joan Houghton
ORCID ID
Contact details
ATAC secretariat
c/o Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
+44 20 3108 7288
j.houghton@ctg.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZEN1033IL/29
Study information
Scientific 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
Acronym
ATAC (Arimidex, Tamoxifen, Alone or in Combination)
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
Overall trial end date
01/12/1999
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/1998
Recruitment end date
01/12/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
ATAC secretariat
London
W1W 7EJ
United Kingdom
Sponsor information
Organisation
AstraZeneca Clinical Research Group (UK)
Sponsor details
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AstraZeneca Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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. 2010 results in https://www.ncbi.nlm.nih.gov/pubmed/21087898
8. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22475046
Publication citations
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Results
Lundgren K, Brown M, Pineda S, Cuzick J, Salter J, Zabaglo L, Howell A, Dowsett M, Landberg G, , Effects of cyclin D1 gene amplification and protein expression on time to recurrence in postmenopausal breast cancer patients treated with anastrozole or tamoxifen: a TransATAC study., Breast Cancer Res., 2012, 14, 2, R57, doi: 10.1186/bcr3161.
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Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker GY, Tobias JS, , Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer., Lancet, 365, 9453, 60-62, doi: 10.1016/S0140-6736(04)17666-6.
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, Buzdar A, Howell A, Cuzick J, Wale C, Distler W, Hoctin-Boes G, Houghton J, Locker GY, Nabholtz JM, Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial., Lancet Oncol., 2006, 7, 8, 633-643, doi: 10.1016/S1470-2045(06)70767-7.
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, Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M, Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial., Lancet Oncol., 2008, 9, 1, 45-53, doi: 10.1016/S1470-2045(07)70385-6.
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Eastell R, Adams JE, Coleman RE, Howell A, Hannon RA, Cuzick J, Mackey JR, Beckmann MW, Clack G, Effect of anastrozole on bone mineral density: 5-year results from the anastrozole, tamoxifen, alone or in combination trial 18233230., J. Clin. Oncol., 2008, 26, 7, 1051-1057, doi: 10.1200/JCO.2007.11.0726.
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Sestak I, Distler W, Forbes JF, Dowsett M, Howell A, Cuzick J, Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC trial., J. Clin. Oncol., 2010, 28, 21, 3411-3415, doi: 10.1200/JCO.2009.27.2021.
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Bosse AW, Douglas JF, Berry BC, Jones RL, Karim A, Block-copolymer ordering with a spatiotemporally heterogeneous mobility., Phys. Rev. Lett., 2007, 99, 21, 216101.