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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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN18233230 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ZEN1033IL/29 |
| 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) |
| Disease/condition/study domain | Breast cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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: a) Aged >60 years b) Bilateral oophorectomy c) Aged <60 years with a uterus and amenorrhoea for at least 12 months d) 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: a) Tamoxifen received prior to first surgical procedure for 28 days or less b) 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 | Not provided at time of registration |
| Patient information material | |
| Anticipated start date | 01/01/1998 |
| Anticipated end date | 01/12/1999 |
| Status of trial | Completed |
| 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 |
| Publications | Results in 1. http://www.ncbi.nlm.nih.gov/pubmed/15639680 2. http://www.ncbi.nlm.nih.gov/pubmed/16887480 (long-term safety analysis) 3. http://www.ncbi.nlm.nih.gov/pubmed/18309940 (five year results) 4. http://www.ncbi.nlm.nih.gov/pubmed/18083636 (100-month analysis) |
| Sources of funding | AstraZeneca Pharmaceuticals (UK) |
| Sponsor name | AstraZeneca Clinical Research Group (UK) |
| Sponsor details | 10 Logie Mill Beaverbank Office Park Lovie Green Road Edinburgh United Kingdom EH7 4HG |
| Sponsor website | http://www.astrazeneca.co.uk |
| Contact name | Ms Joan Houghton |
| Contact details | ATAC secretariat c/o Charles Bell House 67-73 Riding House Street London United Kingdom W1W 7EJ |
| Contact email | j.houghton@ctg.ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN18233230 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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