Skip to content

Epirubicin plus tamoxifen versus tamoxifen alone in post-menopausal node positive primary breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14666896
Enrollment
604
Registered
2002-08-19
Start date
1996-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Breast

Interventions

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

Sponsors

Pharmacia Ltd & Upjohn (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

Belgium, France, Greece, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026