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Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer

Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27799222
Enrollment
Unknown
Registered
2002-08-19
Start date
1987-01-01
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Breast Cancer Breast

Interventions

All patients receive either a total mastectomy or tumour excision followed by radiotherapy. Eligible patients are randomised to receive: A. PRE-MENOPAUSAL PATIENTS 1.

Sponsors

Pharmacia Ltd & Upjohn (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged <65 years 2. Tumour confined to the breast or breast and ipsilateral axilla and considered operable 3. At least one axillary lymph node must show evidence of tumour on histological examination 4. On clinical examination, the axillary nodes should be moveable in relation to the chest wall and neurovascular bundle, and there should be no oedema of the arm 5. Adequate renal, hepatic and haematological function 6. No previous oophorectomy for breast carcinoma 7. No evidence of metastatic disease 8. Patients with advanced disease or ulceration, erythema, infiltration of the skin and oedema are ineligible 9. No previous concomitant malignancy, except squamous or basal cell carcinoma of the skin or carcinoma in-situ of the cervix 10. No non-malignant systemic disease which would preclude the use of any treatment within the trial

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: Feb 4, 2026