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.
- 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
- 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
- Before patient registration/randomization, written informed consent must be given
according to ICH/GCP, and national/local regulations.
- Metastatic disease (M1)
- Prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of
- 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:
- 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
- History of significant neurological or psychiatric disorders that would prohibit
the understanding and giving of informed consent.
- Active uncontrolled infection
- 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
- Concurrent treatment with any other anti-cancer therapy.