eutrophil-guided dosing of anthracycline/cyclophosphamide chemotherapy in patients with breast cancer: a feasibility study

Completed

Conditions: breast cancer
neutrophil count
10006291

Registration Number: NL-OMON34109

Lead Sponsor: Ikazia Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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 (<=17 µmol/L) and serum ASAT and ALAT <=3 times the upper limit of normal (<=5 times the upper limit of normal in case of hepatic metastases)
(7) Normal serum albumin concentration (35-50 g/L)
(8) Written informed consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rather arbitrarily, neutrophil-guided dose escalation will be considered<br /><br>potentially useful if a >=15% dose escalation is feasible in at least three out<br /><br>of thirty patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Assessment of interindividual variability (IIV) in neutrophil counts after a<br /><br>first cycle of anthracyclin/cyclophosphamide chemotherapy (ACC).</p><br>