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 | https://doi.org/10.1186/ISRCTN18233230 |
| Secondary identifying numbers | ZEN1033IL/29 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 06/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Ms Joan Houghton
Scientific
Scientific
ATAC secretariat
c/o Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
| Phone | +44 20 3108 7288 |
|---|---|
| j.houghton@ctg.ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | ATAC (Arimidex, Tamoxifen, Alone or in Combination) |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1998 |
| Overall study end date | 01/12/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| 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 exclusion criteria | Does not match inclusion criteria |
| Recruitment start date | 01/01/1998 |
| Recruitment end date | 01/12/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ATAC secretariat
London
W1W 7EJ
United Kingdom
W1W 7EJ
United Kingdom
Sponsor information
AstraZeneca Clinical Research Group (UK)
Industry
Industry
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
| Website | http://www.astrazeneca.co.uk |
|---|---|
"ROR" |
https://ror.org/04r9x1a08 |
Funders
Funder type
Industry
AstraZeneca Pharmaceuticals (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2005 | Yes | No | |
| Results article | results of long-term safety analysis | 01/08/2006 | Yes | No | |
| Results article | results on 10 year analysis of trial | 23/11/2007 | Yes | No | |
| Results article | results of 100-month analysis | 01/01/2008 | Yes | No | |
| Results article | five year results | 01/03/2008 | Yes | No | |
| Results article | results on the effect of body mass index on recurrence rates | 20/07/2010 | Yes | No | |
| Results article | results | 01/12/2010 | Yes | No | |
| Results article | results | 04/04/2012 | Yes | No |
