Epirubicin plus tamoxifen versus tamoxifen alone in post-menopausal node positive primary breast cancer
ISRCTN | ISRCTN14666896 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN14666896 |
Secondary identifying numbers | ICCG/4/87 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 12/08/2008
- 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 - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Breast cancer |
Intervention | 1. Regimen A: tamoxifen 20 mg daily for 4 years 2. Regimen B: tamoxifen 20 mg daily for 4 years plus chemotherapy, single agent epirubicin repeated every 4 weeks for six cycles |
Intervention type | Other |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1996 |
Completion date | 28/02/1998 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Female |
Target number of participants | 604 |
Key inclusion criteria | 1. Post-menopausal as determined by: 1.1. Last menstrual cycle 12 months before surgery 1.2. Patients any age with previous bilateral oophorectomy 1.3. Patients aged greater than 50 years who have had hysterectomy without oopherectomy as long as the reason for surgery was not a malignancy 2. Aged less than 75 years 3. Histologically proven non metastatic T1-T3 with at least one involved ipsilateral axillary node 4. Adequate renal and haematological function 5. No prior history of malignant breast tumours 6. No bilateral malignancy or inflammatory breast cancer 7. No previous or concomitant malignancy, except squamous or basal cell carcinoma of the skin which has been effectively treated or carcinoma of the cervix in situ which has been treated operatively only 8. No non malignant systemic disease 9. No definite indication for chemotherapy |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/01/1996 |
Date of final enrolment | 28/02/1998 |
Locations
Countries of recruitment
- Belgium
- England
- France
- Greece
- Netherlands
- Spain
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
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 |
https://ror.org/04x4v8p40 |
Funders
Funder type
Industry
Pharmacia and Upjohn Ltd (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 | 01/07/1999 | Yes | No |