Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICCG/4/87
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
28/02/1998
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
604
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1996
Recruitment end date
28/02/1998
Locations
Countries of recruitment
Belgium, France, Greece, Netherlands, Spain, United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Pharmacia Ltd & Upjohn (UK)
Sponsor details
Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
+44 (0)1908 661101
info@adreco.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pharmacia and Upjohn Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10561249
Publication citations
-
Results
Wils JA, Bliss JM, Marty M, Coombes G, Fontaine C, Morvan F, Olmos T, Pérez-López FR, Vassilopoulos P, Woods E, Coombes RC, Epirubicin plus tamoxifen versus tamoxifen alone in node-positive postmenopausal patients with breast cancer: A randomized trial of the International Collaborative Cancer Group., J. Clin. Oncol., 1999, 17, 7, 1988-1998.