caelyx adjuvant in elderly breast cancer

Conditions: Breast Cancer; Elderly

Summary: this is an open label phase ii study in elderly patients (65y or older) with early breast cancer who are candidate for adjuvant chemotherapy. a scheme with liposomal doxorubicin (caelyx) and cyclophosphamide (endoxan) will be used. the aim is to study the cardiac effects of liposomal doxorubicin with new non-invasive techniques, ie strain rate imaging, classical echocardiography, and special blood tests measuring troponin i and bnp.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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: * 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 study entry. * concurrent treatment with any other anti-cancer therapy.

Keywords: breast cancer elderly adjuvant chemotherapy caelyx