Condition category
Cancer
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Mark Webster-Smith

ORCID ID

Contact details

Clinical Trials & Statistics Unit (ICR-CTSU)
Section of Clinical Trials
Brookes Lawley Building
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
Mark.Webster-Smith@icr.ac.uk

Additional identifiers

EudraCT number

2004-000168-28

ClinicalTrials.gov number

Protocol/serial number

1306

Study information

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

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. Chemotherapy, tamoxifen and ovarian ablation are individually effective adjuvant treatments in women under 50 with ER+ breast cancer and combined chemotherapy plus tamoxifen is known to be more effective than chemotherapy alone. The body of evidence for aromatase inhibitors as adjuvant treatment for post-menopausal breast cancer will increase over the next few years thus it is timely to assess the role of an aromatase inhibitor added to OFS in pre-menopausal women. All patients receive primary surgery +/- radiotherapy +/- chemotherapy and are randomised to tamoxifen plus GnRH for 5 years or exemestane plus GnRH for 5 years. 1845 patients are required internationally. The trial has 80% power to detect a 25% reduction in hazard; the primary endpoint is disease-free survival. It is hoped that this clinical study will establish a clear rationale for the use of tamoxifen or exemestne in addition to OFS in pre-menopausal women with hormone responsive breast cancer.

Ethics approval

Oxford Research Ethics Committee B approved on the 3rd November 2004 (ref: 04/MRE06/04)

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase III

Drug names

Tamoxifen, exemestane

Primary outcome measures

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 trial start date

07/11/2003

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 1845

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

Germany, Sweden, United Kingdom

Trial participating centre

Clinical Trials & Statistics Unit (ICR-CTSU)
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

International Breast Cancer Study Group (IBCSG) (Switzerland)

Sponsor details

Effingerstrasse 40
Bern
3008
Switzerland

Sponsor type

Research organisation

Website

http://www.ibcsg.org/Pages/default.aspx

Funders

Funder type

Research organisation

Funder name

International Breast Cancer Study Group (IBCSG) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes