|
ISRCTN
|
ISRCTN11883920
|
|
ClinicalTrials.gov identifier
|
|
|
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
|
|
|
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
|
|
|
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
|
|
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
|
02/02/2011
|
|
Date ISRCTN assigned
|
19/08/2002
|
