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
A randomised double-blind trial in post-menopausal women with primary breast cancer who have received adjuvant tamoxifen for 2-3 years, comparing subsequent adjuvant exemestane treatment with further tamoxifen
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 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 measure
Disease-free survival
Secondary outcome measures
Overall survival
Overall trial start date
01/01/1998
Overall trial end date
31/12/2003
Reason abandoned (if study stopped)
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
Weston Park Hospital
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
info@adreco.co.uk
Sponsor type
Industry
Website
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
Basic results (scientific)
Publication list
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
2017 long-term follow-up results in: https://www.ncbi.nlm.nih.gov/pubmed/28467729
Publication citations
-
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.
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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.
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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.
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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.