Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr RE Coleman


Contact details

Academic Unit of Clinical Oncology
Cancer Research Centre
Weston Park Hospital
S10 2RX
United Kingdom
+44 (0)114 271 3518

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Breast cancer


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



Not Applicable

Drug names

Tamoxifen, exemestane

Primary outcome measures

Disease-free survival

Secondary outcome measures

Overall survival

Overall trial start date


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


Participant exclusion criteria

Not provided at time of registration

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Clinical Oncology
S10 2RX
United Kingdom

Sponsor information


Pharmacia Ltd & Upjohn (UK)

Sponsor details

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

Sponsor type




Funder type


Funder name

Pharmacia and Upjohn (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:
2007 survival and safety results in:
2012 5-year follow-up study results in:
2012 retrospective analysis in:

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.

Editorial Notes