Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
12/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 measures

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

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

http://www.pharmacia.com

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

Results - basic reporting

Publication summary

1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10561249

Publication citations

  1. 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.

Additional files

Editorial Notes