Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
09/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr RE Coleman

ORCID ID

Contact details

Academic Unit of Clinical Oncology
Cancer Research Centre
Weston Park Hospital
Sheffield
S10 2RX
United Kingdom
+44 (0)114 271 3518
R.E.Coleman@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

960EXE031

Study information

Scientific title

Acronym

Study hypothesis

Early improvements in disease-free survival have been noted when an aromatase inhibitor is given either instead of or sequentially after tamoxifen in postmenopausal women with oestrogen-receptor-positive early breast cancer. However, little information exists on the long-term effects of aromatase inhibitors after treatment, and whether these early improvements lead to real gains in survival.

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Breast cancer

Intervention

1. Patients in the reference arm will receive an overall course of tamoxifen for 5 years (20 mg/day)
2. Patients in the investigational arm will receive 25 mg/day exemestane (after 2-3 years tamoxifen giving a total of 5 years endocrine therapy)

Intervention type

Drug

Phase

Not Applicable

Drug names

Tamoxifen, exemestane

Primary outcome measures

Disease-free survival

Secondary outcome measures

Overall survival

Overall trial start date

01/01/1998

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically/cytologically confirmed unilateral operable breast adenocarcinoma
2. Estrogen receptor (ER)+ or ER unknown
3. Adequate therapy for primary disease
4. Postmenopausal
5. Receiving tamoxifen and treated with tamoxifen for 2-3 years
6. Remain free from disease following treatment for primary disease

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

4724

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1998

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Clinical Oncology
Sheffield
S10 2RX
United Kingdom

Sponsor information

Organisation

Pharmacia Ltd & Upjohn (UK)

Sponsor details

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
+44 (0)1908 661101

Sponsor type

Industry

Website

http://www.pharmacia.com

Funders

Funder type

Industry

Funder name

Pharmacia and Upjohn (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

2004 results of the 2nd interim analysis of efficacy in: http://www.ncbi.nlm.nih.gov/pubmed/15014181
2007 survival and safety results in: http://www.ncbi.nlm.nih.gov/pubmed/17307102
2012 5-year follow-up study results in: http://www.ncbi.nlm.nih.gov/pubmed/22353807
2012 retrospective analysis in: http://www.ncbi.nlm.nih.gov/pubmed/22265698

Publication citations

  1. Survival and safety results

    Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, Jassem J, Van de Velde CJ, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates AS, Bajetta E, Holmberg SB, Dodwell D, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield LJ, Bertelli G, Hall E, Bogle RG, Carpentieri M, Colajori E, Subar M, Ireland E, Bliss JM, , Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial., Lancet, 2007, 369, 9561, 559-570, doi: 10.1016/S0140-6736(07)60200-1.

  2. Retrospective analysis

    Mieog JS, Morden JP, Bliss JM, Coombes RC, van de Velde CJ, , Carpal tunnel syndrome and musculoskeletal symptoms in postmenopausal women with early breast cancer treated with exemestane or tamoxifen after 2-3 years of tamoxifen: a retrospective analysis of the Intergroup Exemestane Study., Lancet Oncol., 2012, 13, 4, 420-432, doi: 10.1016/S1470-2045(11)70328-X.

  3. Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, van de Velde C, , A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer., N. Engl. J. Med., 2004, 350, 11, 1081-1092, doi: 10.1056/NEJMoa040331.

  4. Fallowfield LJ, Kilburn LS, Langridge C, Snowdon CF, Bliss JM, Coombes RC, , Long-term assessment of quality of life in the Intergroup Exemestane Study: 5 years post-randomisation., Br. J. Cancer, 2012, 106, 6, 1062-1067, doi: 10.1038/bjc.2012.43.

Additional files

Editorial Notes