Breast cancer Cancer Breast cancer
Conditions
Interventions
Patients should be treated according to the following schedule:
D1 Epirubicin 100 mg/m^2 intravenous (i.v) administration
D2 Pegfilgrastim 6 mg single dose subcutaneous
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of invasive early breast cancer with complete excision following surgery 2. No evidence of metastatic disease 3. Clear indication for adjuvant chemotherapy based on clinical and histopathological features 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 5. Clinically assessed as fit to undergo E-CMF chemotherapy at full dose a. Haematological parameters within normal range for institution b. Liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) =1.5 upper limit of normal (ULN) c. Adequate renal function with creatinine clearance >50 ml/min (calculated according to Cockcroft formula) 6. No previous chemotherapy or radiotherapy 7. Aged 18 years and over 8. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active 9. Written informed consent obtained 10. No concomitant medical or psychiatric problems that might prevent completion of treatment
Exclusion criteria
Exclusion criteria: 1. Significant history of cardiac disease (prior myocardial infarction, angina, uncontrolled hypertension) 2. Any co-morbidity significantly adding to risks associated with cytotoxic chemotherapy for instance: severe chronic obstructive pulmonary disease, poorly controlled diabetes etc 3. Recent exposure to immunosuppressive drugs including oral corticosteroid 4. Inability to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delivered dose intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity and safety | — |
Countries
United Kingdom
Outcome results
None listed