Research project
Title: ATAC Trial (Arimidex, Tamoxifen, Alone, and in Combination. (An adjuvant drug trial for women with early post-menopausal breast cancer.)
Project timescale: From 30 January, 1996
(Added to website on: 07 March, 2005 - Date last updated: 06 February, 2013)
Source of funding:
For the Trial: AstraZeneca; UKCCCR (United Kingdom Cancer Co-ordinating Committee for Cancer Research)
Aims: To compare tamoxifen with a) Arimidex, and b) tamoxifen plus Arimidex, in eligible post-menopausal women with surgically resected, histologically proven invasive early breast cancer. Recurrence-free survival and side effects were the primary endpoints. Distant disease-free interval, survival and contralateral breast cancer were secondary endpoints. Parallel studies (for some centres only) considered pharmacological interactions of Arimidex and tamoxifen; monitored endometrial changes, bone mineral density and quality of life. (The CAG-CT were not involved in these.)
Research designs used:
Randomised controlled trial
Other:
Methods used to collect data:
Documentary analysis
Questionnaire survey
Other (please specify): Collated comments from CAG-CT members on the protocol and patient information sheet were requested and supplied.
Research project description: The ATAC Trial was a three-arm, multi-centre, randomised, double-blind placebo controlled trial. The CAG-CT was invited 13th February 1996, by the Trial Chairman on behalf of its steering committee, to comment on the draft trial protocol, then near to finalisation. Copies of the protocols were sent to members of the group on 16th February. Collated comments were required by 27th February. Collated comments were sent 26th February. A further opportunity to comment on the patient information sheet was given in May 1996, required and sent off by mid July 1996
Stages at which the public were involved:
Other: Pre trial talk with researchers, draft protocol, patient information leaflet.
Description of public involvement in research stages: The Chairman of the CAG-CT was invited pre-trial to talk to involved Zeneca personnel about the patient`s viewpoint of participating in randomised controlled trials. This was to give insight into the patient`s view of trial participation and to respond to questions. CAG-CT commented on draft protocol just prior to its finalisation. Commented, with one iteration, on patient information leaflet. CAG-CT Chairman `launched` the trial in December 1996 at official launch meeting; attended investigators` meeting post-trial in March 2002; published comment in the Lancet; and offered comment at appropriate breast cancer meetings.
Training and support provided for either members of the public or researchers involved in the project:
Examples of ways the public have made a difference to the research project: The Chairman of the CAG-CT was able to sensitize involved pharmaceutical personnel to aspects of trial participation, as seen from a patient`s point of view, prior to the trial protocol full formulation. The CAG-CT, by accepting the challenge to offer comment on a complex draft drug-trial protocol (joint pharmaceutical and charity funded) at extremely short notice, demonstrated the ability to organise and provide (quote) 'helpful' and acceptable patient input - the first such invitation for this type of trial. Some suggestions, relating both to the trial protocol and the patient information leaflet, were taken up by the trial organisers. Launch of the trial by the CAG-CT Chairman emphasised endorsement of `patient-as-researcher` contribution and involvement to all those who attended: these included clinical representatives from nationwide participating centres, and pharmaceutical personnel
Evaluating the impact of public involvement in the research:
Details of publications or reports resulting from the research: The two major publications are: (i) The ATAC Trialists Group. Anastrozole alone or in combination with tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet 2002; 359:2131-2139 (ii) Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker GY, Tobias JS; ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet. 2005 Jan 1;365(9453):60-2. This was a very high profile trial: numerous media reports, commentaries and presentations at major breast cancer conferences have been offered. (iii) How Rapidly Do Oncologists Respond to Clinical Trial Data? The Oncologist, Vol. 10, No. 1, 15-21, January 2005 http://theoncologist.alphamedpress.org/cgi/content/abstract/10/1/15?ijkey=43 (iv) `Involved consumer` published comment: Letter: Thornton H. Anastrozole as a preventive agent in breast cancer. Lancet. 2003; 361: 1911-2. (v) Letter. Thornton H. Questions about anastrozole for early breast cancer. Lancet. (2002) 360:1890. Published together with `author`s reply` by Michael Baum on behalf of the ATAC Steering Committee. Later updates and further comment will no doubt continue to be published on this major trial.
Links to Reports:
Was/is your project user controlled: Not Known
For further information on the project, please contact:
Hazel Thornton
Chairman of CAG-CT, responsible for liaison
Consumers` Advisory Group for Clinical Trials (CAG-CT
31 Regent Street
Rowhedge
Colchester
CO5 7EA
hazelcagct@keme.co.uk
01206 728178
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