breast cancer neutrophil count
Conditions
Interventions
Patients with clinically non-significant (grade 0-2) neutropenia and no other
dose-limiting toxicity after the first cycle of chemotherapy will undergo a
10-25% (depending on the course of ANC) dose
Sponsors
Ikazia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) breast cancer patients aged >=18 years planned for treatment with at least three cycles of one of the above-mentioned ACC-regimens (AC, FAC, or FEC) at the Department of Medical Oncology, Ikazia Hospital, Rotterdam, The Netherlands (2) WHO performance status 0-1 (3) Life expectancy >3 months (4) Adequate peripheral blood counts: leukocytes >=4.0x109/L and ANC >=2.0x109/L and platelet count >=150x109/L (5) Adequate renal function defined as normal serum creatinine concentration and/or estimated creatinine clearance >=60 mL/min (by Cockroft-Gault formula: [140 - age (years)] x 1.05 x body weight (kg)] : serum creatinine concentration (µmol/L)) (6) Adequate liver function defined as normal serum bilirubin concentration (
Exclusion criteria
Exclusion criteria: (1) Previous treatment with chemotherapy (2) Unable to consent with weekly follow-up for blood counts and toxicity assessment (3) Symptomatic brain metastasis (4) History of cardiac dysfunction (5) Uncontrolled arterial hypertension (blood pressure systolic >=180 mmHg and/or diastolic >=110 mmHg) and/or unstable angina pectoris
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rather arbitrarily, neutrophil-guided dose escalation will be considered potentially useful if a >=15% dose escalation is feasible in at least three out of thirty patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of interindividual variability (IIV) in neutrophil counts after a first cycle of anthracyclin/cyclophosphamide chemotherapy (ACC). | — |
Countries
Netherlands
Outcome results
None listed