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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
Intervention1. 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1996
Completion date28/02/1998

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants604
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1996
Date of final enrolment28/02/1998

Locations

Countries of recruitment

  • Belgium
  • England
  • France
  • Greece
  • Netherlands
  • Spain
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Pharmacia Ltd & Upjohn (UK)
Industry

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom

Phone +44 (0)1908 661101
Email info@adreco.co.uk
Website http://www.pharmacia.com
ROR logo "ROR" 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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