A Randomised Comparative Trial of Infusional ECF versus Conventional FEC as Adjuvant Chemotherapy in Patients with Poor Prognosis Breast Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83324925

Enrollment

348

Registered

2002-08-19

Start date

1995-06-26

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 Malignant neoplasm of breast

Interventions

1. Infusional ECF Regimen: Chemotherapy, infusional ECF (epirubicin, cyclophosphamide, 5-fluorouracil) 2. FEC Regimen: Chemotherapy, conventional FEC (epirubicin, cyclophosphamide, 5-fluorouracil)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Confirmed invasive carcinoma of the breast 2. Treatment to start within 3 months of surgery 3. World Health Organisation (WHO) performance status of zero or one 4. Patients assessed as being competent to learn to look after Infumed or Graseby pump 5. No evidence of metastatic disease (routine Chest X-RAY [CXR], biochemistry) 6. Adequate haematological function 7. A glomerular filtration rate of greater than or equal to 60mls/minute. This can be measured by using an EDTA clearance or 24 hour urinary creatinine clearance at the investigators discretion 8. No other serious uncontrolled medical condition 9. No other malignancy, except carcinoma in situ of the cervix of basal cell carcinoma of the skin 10. Histologically proven invasive breast cancer (excision specimen or Trucut biopsy) 11. Upper age limit 50 years 12. Histologically involved axillary nodes 13. Written informed consent 14. Other investigations, e.g. bone scan, liver ultrasound, are only required for symptoms and/or abnormal biochemistry

Exclusion criteria

Exclusion criteria: 1. Any patient with a medicinal or psychiatric condition that impairs their ability to cope physically or psychologically with this chemotherapy regimen, or to give informed consent 2. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled or cardiac arrhythmias 3. Any other serious uncontrolled medical condition 4. Any pregnant or lactating woman 5. Other malignancy (excluding carcinoma in situ of cervix)

Design outcomes

Primary

Measure	Time frame
Not provided at time of registration	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

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