Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
07/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
j.houghton@ctg.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZEN1033IL/29

Study information

Scientific title

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

http://www.astrazeneca.co.uk

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22475046

Publication citations

  1. 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.

  2. 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.

  3. , 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.

  4. , 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.

  5. 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.

  6. 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.

  7. 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.

Additional files

Editorial Notes