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 | https://doi.org/10.1186/ISRCTN11883920 |
| Secondary identifying numbers | 960EXE031 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 19/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr RE Coleman
Scientific
Scientific
Academic Unit of Clinical Oncology
Cancer Research Centre
Weston Park Hospital
Sheffield
S10 2RX
United Kingdom
| Phone | +44 (0)114 271 3518 |
|---|---|
| R.E.Coleman@sheffield.ac.uk |
Study information
| Study design | Randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tamoxifen, exemestane |
| Primary outcome measure | Disease-free survival |
| Secondary outcome measures | Overall survival |
| Overall study start date | 01/01/1998 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 4724 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Weston Park Hospital
Sheffield
S10 2RX
United Kingdom
S10 2RX
United Kingdom
Sponsor information
Pharmacia Ltd & Upjohn (UK)
Industry
Industry
Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
| Phone | +44 (0)1908 661101 |
|---|---|
| info@adreco.co.uk | |
| Website | http://www.pharmacia.com |
"ROR" |
https://ror.org/04x4v8p40 |
Funders
Funder type
Industry
Pharmacia and Upjohn (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of the 2nd interim analysis of efficacy | 11/03/2004 | Yes | No | |
| Results article | survival and safety results | 17/02/2007 | Yes | No | |
| Results article | 5-year follow-up study results | 13/03/2012 | Yes | No | |
| Other publications | retrospective analysis | 01/04/2012 | Yes | No | |
| Results article | long-term follow-up results | 01/08/2017 | Yes | No |
Editorial Notes
19/10/2017: Publication reference added.
