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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
ISRCTN ISRCTN11883920
DOI 10.1186/ISRCTN11883920
ClinicalTrials.gov identifier
EudraCT number
Public 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
Scientific title
Acronym N/A
Serial number at source 960EXE031
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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised double-blind controlled trial
Countries of recruitment International
Disease/condition/study domain Breast cancer
Participants - 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
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/01/1998
Anticipated end date 31/12/2003
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 4724
Interventions 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)
Primary outcome measure(s) Disease-free survival
Secondary outcome measure(s) Overall survival
Sources of funding Pharmacia and Upjohn (UK)
Trial website
Publications 1. 2004 results of the 2nd interim analysis of efficacy in http://www.ncbi.nlm.nih.gov/pubmed/15014181
2. 2007 survival and safety results in http://www.ncbi.nlm.nih.gov/pubmed/17307102
3. 2010 reversal of skeletal effects results in http://www.ncbi.nlm.nih.gov/pubmed/16542012
4. 2012 5 - year follow up study results in http://www.ncbi.nlm.nih.gov/pubmed/22353807
5. 2012 retrospective analysis in http://www.ncbi.nlm.nih.gov/pubmed/22265698
Contact name Dr  RE  Coleman
  Address Academic Unit of Clinical Oncology,
Cancer Research Centre,
Weston Park Hospital,
  City/town Sheffield
  Zip/Postcode S10 2RX
  Country United Kingdom
  Tel +44 (0)114 271 3518
  Fax +44 (0)114 271 1711
  Email R.E.Coleman@sheffield.ac.uk
Sponsor Pharmacia Ltd & Upjohn (UK)
  Address Davy Avenue
  City/town Milton Keynes
  Zip/Postcode MK5 8PH
  Country United Kingdom
  Tel +44 (0)1908 661101
  Fax +44 (0)1908 690091
  Email
  Sponsor website: http://www.pharmacia.com
Date applied 19/08/2002
Last edited 26/06/2012
Date ISRCTN assigned 19/08/2002
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