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A randomised trial of standard anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and CMF (Epi-CMF) versus FEC followed by sequential docetaxel as adjuvant treatment for women with early breast cancer

A randomised trial of standard anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and CMF (Epi-CMF) versus FEC followed by sequential docetaxel as adjuvant treatment for women with early breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79718493
Enrollment
3340
Registered
2001-07-01
Start date
2001-05-20
Completion date
Unknown
Last updated
2018-11-12

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

Control Arm A: 5- Fluorouracil (5-FU) (600 mg/m^2 intravenous [iv] bolus), Epirubicin (60 mg/m^2 iv bolus), Cyclophosphamide (600 mg/m^2 iv bolus) x eight cycles at three weekly intervals. Control Ar

Sponsors

Sponsor not defined - Record supplied by Institute of Cancer Research
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with operable histologically confirmed completely resected invasive breast cancer for whom adjuvant chemotherapy is indicated 2. No clinical or radiological evidence of locoregional or metastatic disease based on standard staging procedures at local centres 3. World Health Organisation (WHO) performance status of zero or one 4. Chemotherapy to start within eight weeks from date of definitive surgery 5. Aged over 18 years (no upper age limit) 6. Hormone receptor status to be determined prior to randomisation 7. Adequate renal, hepatic and bone marrow function 8. Signed written informed consent

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

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026