Tamoxifen and Exemestane Trial

ISRCTN	ISRCTN66949472
DOI	https://doi.org/10.1186/ISRCTN66949472
EudraCT/CTIS number	2004-000168-28
ClinicalTrials.gov number	NCT00066703
Secondary identifying numbers	1306

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 20/05/2024

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-different-hormone-therapies-for-pre-menopausal-women-with-breast-cancer

Study website

Contact information

Mr Mark Webster-Smith
Scientific

Clinical Trials & Statistics Unit (ICR-CTSU)
Section of Clinical Trials
Brookes Lawley Building
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Phone	+44 20 8722 4013
Email	Mark.Webster-Smith@icr.ac.uk

Study information

Study design	Multicentre randomized interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The role of ovarian function suppression (OFS) in premenopausal women with hormone responsive early breast cancer: tamoxifen versus exemestane - a multicentre randomised interventional trial
Study acronym	TEXT
Study hypothesis	Tamoxifen versus Exemestane Trial (TEXT) is one of three trials being launched by the International Breast Cancer Study Group to determine the role of ovarian function suppression (OFS) in pre-menopausal women with hormone responsive early breast cancer.
Ethics approval(s)	Approved 03/11/2004, South West- Cornwall and plymouth (cornwallandplymouth.rec@hra.nhs.uk, Bristol, CB22 2QQ, United Kingdom; +44 (0)207 104 8143; cornwallandplymouth.rec@hra.nhs.uk), ref: 04/MRE06/04
Condition	Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention	Group A: Randomisation prior to receiving any adjuvant systemic therapy. Triptorelin for 5 years plus. Chemotherapy (CT), if used, should begin at the same time as triptorelin. Use of CT may be determined by randomisation in the PERCHE trial or by investigator/patient choice. Tamoxifen will then be provided for 5 years. Tamoxifen should start after adjuvant chemotherapy has been completed or approximately six to eight weeks after the initiation of triptorelin, whichever is later. Group B: Randomisation prior to receiving any adjuvant systemic therapy. Triptorelin for 5 years plus. Chemotherapy (CT), if used, should begin at the same time as triptorelin. Use of CT may be determined by randomisation in the PERCHE trial or by investigator/patient choice. Exemestane will then be provided for 5 years. Exemestane should start after adjuvant chemotherapy has been completed or approximately six to eight weeks after the initiation of triptorelin, whichever is later. Follow up length: 120 months Study entry: registration and one or more randomisations
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Tamoxifen, exemestane
Primary outcome measure	Disease-free survival
Secondary outcome measures	1. Causes of death without cancer event 2. Incidence of second (non-breast) malignancies 3. Late side effects of early menopause 4. Overall survival 5. Quality of life 6. Sites of first treatment failure 7. Systemic disease-free survival
Overall study start date	07/11/2003
Overall study end date	21/02/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned sample size: 1845
Total final enrolment	2672
Participant inclusion criteria	1. Pre-menopausal women (oestradiol [E2] levels in the premenopausal range), aged above 18 years 2. Histologically proven, resected breast cancer. Pathology material should be available for submission for central review. 3. Hormone receptor positive (HR+) tumour. HR must be determined using immunohistochemistry (IHC): oestrogen receptor (ER) and/or progesterone receptor (PgR) greater than or equal to 10%. 4. Tumour confined to the breast and axillary nodes without detected metastases elsewhere with the exception of tumour detected in the internal mammary chain nodes by sentinel node procedure 5. Proper surgery (total mastectomy or breast conserving procedure plus radiation) for primary disease with no known clinical residual disease 6. Axillary lymph node dissection or negative axillary sentinel node biopsy 7. Written informed consent and accessible for follow-up 8. Patients must be informed of and agree to data and tissue transfer and handling, in accordance with national data protection guidelines
Participant exclusion criteria	1. Postmenopausal 2. Distant metastatic disease 3. Locally advanced inoperable breast cancer 4. Bilateral invasive breast cancer 5. Positive final margins 6. Clinically detectable residual axillary disease 7. History of previous ipsilateral or contralateral invasive breast cancer 8. Previous or concomitant malignancy except adequately treated basal/squamous cell carcinoma of the skin, in-situ carcinoma of the cervix or bladder, contralateral or ipsilateral in-situ breast cancer 9. Other non-malignant systemic diseases that would prevent prolonged follow-up 10. Patients who have had a bilateral oophorectomy or ovarian irradiation 11. History of noncompliance to medical regimens or considered potentially unreliable 12. Previous or concomitant malignancy except adequately treated basal/squamous cell carcinoma of the skin, in-situ carcinoma of the cervix or bladder, contralateral or ipsilateral in-situ breast cancer 13. Other non-malignant systemic diseases that would prevent prolonged follow-up
Recruitment start date	07/11/2003
Recruitment end date	31/05/2008

Locations

Countries of recruitment

England
Germany
Sweden
United Kingdom

Study participating centre

Clinical Trials & Statistics Unit (ICR-CTSU)

Sutton
SM2 5NG
United Kingdom

Sponsor information

International Breast Cancer Study Group (IBCSG)
Research organisation

Effingerstrasse 40
Bern
3008
Switzerland

Website	http://www.ibcsg.org/Pages/default.aspx
"ROR"	https://ror.org/05b2gms10

Funders

Funder type

Research organisation

International Breast Cancer Study Group

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?
Plain English results				No	Yes
Basic results			09/09/2019	No	No
Results article	results	10/07/2014	09/09/2019	Yes	No

Editorial Notes

20/05/2024: Total final enrolment added.
10/05/2024: Ethics approval details added. The overall study end date was changed from 31/05/2008 to 21/02/2024.
09/09/2019: ClinicalTrials.gov number, publication reference and basic results link added.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
15/03/2017: No publications found in PubMed, verifying study status with principal investigator