An open label Phase II trial to investigate the cardiac effects of pegylated liposomal doxorubicine (Caelyx?) in elderly breast cancer patients with new imaging and biochemical techniques.
- Conditions
- histologically proven early breast cancer requiring adjuvant chemotherapy according to the treating physician (lymph node positive or other features of high risk according to St-Gallen criteria). 16 evaluable elderly patients (65 y or older) with high risk early breast cancer requiring adjuvant chemotherapy.
- Registration Number
- EUCTR2005-002995-13-BE
- Lead Sponsor
- ZLeuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 16
Patients must meet all of the following inclusion criteria in order to be eligible for participation in this study:
•histologically proven early breast cancer requiring adjuvant chemotherapy according to the treating physician (lymph node positive or other features of high risk according to St-Gallen criteria).
•Age ? 65 years
•Normal cardiac function (assessment of LVEF by MUGA scan or echocardiography above the lower limit of normal for the institution).
•Performance status 0 to 2 (WHO scale)
•The determination of ER and PgR is mandatory (immunohistochemical methods required; ER and/or PgR positivity is defined as > 1% of positive cells). Also determination of Her2neu is mandatory, either by immunohistochemistry or by FISH
•Adequate organ function (as defined by neutrophils ? 1.5 x109/L, Platelets ? 100 x 109/L, Hemoglobin ? 10 g/dl, total bilirubin ? 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) ? 1.5 UNL, alkaline phosphatase ? 2.5 UNL, creatinine ? 1.5 mg/dl (150 µmol/L)
•Complete staging work-up within 2 months prior to registration. All patients will have bilateral mammography, chest X-ray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. In case of positive bone scan suspicious for metastases, bone X-ray (or bone CT-scan on spinal hot spots) is mandatory to rule out the possibility of metastatic disease. Other tests may be performed as clinically indicated.
•Patients must be accessible for treatment and follow-up.
•absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Metastatic disease (M1)
•prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of immunotherapy)
•prior radiation therapy for breast cancer.
•pre-existing motor or sensory neurotoxicity of a severity ? grade 2 by NCI criteria.
•serious illness or medical condition:
a/ congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrythmias
b/ history of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
c/ active uncontrolled infection
d/ active peptic ulcer, unstable diabetes.
•past (less than 5 years) or current history of other neoplasm except for curatively treated basal cell skin cancer or in situ carcinoma of the cervix.
•concurrent treatment with hormonal replacement therapy: this treatment should be stopped at least 15 days before study entry
•concurrent treatment with other experimental drugs. No participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
•concurrent treatment with any other anti-cancer therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: We would like to investigate the effect of Caelyx? on cardiac function using three new methods to assess cardiac function, namely (i) SRI (strain rate imaging), (ii) BNP and (iii) Troponin I. Secondarily relate these findings to the classical EF measurement. The early detection of cardiac dysfunction might allow switching over from adriamycin to caelyx in an earlier stage, thus preventing development of significant cardiac failure.;Secondary Objective: To assess the tolerability of Caelyx? containing regimens in elderly breast cancer patients.;Primary end point(s): Is SRI decreased after 6 cycles of Caelyx?-Cyclophophamide ?
- Secondary Outcome Measures
Name Time Method