Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease).
Conditions
Interventions
Trade Name: Caelyx
Product Name: Caelyx
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: doxorubicine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
Schering-Plough CE AG Hungarian Commercial Representative Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease). - Prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m2 and 430mg/m2 and 18 years of age. - Documented measurable and/or evaluable metastatic breast cancer by appropriate radiological imaging (CT scan and/or MRI). - Performance status of at least 60% (Karnofsky index) and a life expectancy of at least 12 weeks. - Left ventricular ejection fraction > 50%. - Normal organ function, except if abnormal due to tumor involvement. Adequate bone marrow function as indicated: Platelets > 100,000/mm3 Hemoglobin > 9 g/dL Neutrophils > 1,500/mm3 Adequate renal function as indicated by: Serum Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient is pregnant or is breast feeding. - Patients with moderate or severe heart failure (NYHA class III/IV). - Patient is hypersensitive to anthracycline therapy or has a history of severe hypersensitivity reactions to products containing Cremophor EL (e.g., cyclosporin for injection concentrate and teniposide for injection concentrate). - Age < 18 years. - Prior chemotherapy for metastatic disease. - Clinically significant hepatic disease (except liver metastases of primary disease). - Patient has uncontrolled bacterial, viral, or fungal infection. - Radiotherapy in the last 4 weeks or prior radiation therapy to more than one-third of the hemopoietic sites. - Any other currently known malignancy or pre-malignant lesions or any history of other malignancy within the past five years (except non-melanoma skin cancer and surgically cured cervical cancer). - Patient has symptomatic metastasis to the brain. - Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care. - Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease. - Documented HIV infection. - Any condition (medical, social, psychological) which would prevent adequate follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the cardiac safety profile of first line Caelyx chemotherapy in metastatic breast cancer patients with prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m2 and 430mg/m2 and 20 points from baseline if the resting LVEF remains in the normal range, or a decrease of >10 points if the LVEF became abnormal (lower than the institutional lower limit of normal). | — |
Countries
Hungary
Outcome results
None listed