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
Protocol serial number	ZEN1033IL/29
Sponsor	AstraZeneca Clinical Research Group (UK)
Funder	AstraZeneca Pharmaceuticals (UK)

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 of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-comparing-anastrozole-and-tamoxifen-after-surgery-for-breast-cancer

Contact information

Ms Joan Houghton
Scientific

ATAC secretariat
c/o Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom

Phone	+44 20 3108 7288
Email	j.houghton@ctg.ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/1998
Date of final enrolment	01/12/1999

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

ATAC secretariat

London
W1W 7EJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes