Locally advanced and/or metastatic breast cancer, not amenable to surgery. MedDRA version: 8.1 Level: PT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Trade Name: Caelyx 2 mg/ml concentrate for solution for infusion
Product Name: DOXIL/CAELYX
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOXORUBICIN HYDROCHLORIDE
CA
Sponsors
Schering-Plough AB Sweden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female patients with histologic or cytologic diagnosis of breast cancer that is inoperable locally advanced or metastatic. 2. Age = 65 years. 3. WHO Performance Status 0 - 2 4. Measurable disease in accordance with RECIST criteria. Patients with bone metastasis can also be included but will be evaluated according to WHO criteria. Patients with non-measurable disease can also be included. 5. LVEF =50% verified by UCG, no clinical signs of heart disease 6. Normal organ function, except due to disease involvement, however maximum deviation: a. Creatinine = 1.5 x upper normal limit b. Bilirubin = 2 x upper normal limit c. ALAT and/or ASAT = 3 x upper normal limit. In case of liver metastases, ALAT and/or ASAT = 5 x upper normal limit. 7. Adequate bone marrow function, i.e.: d. Platelets =100 x 1 000 000 000/L e. Neutrophils =1,5 x 1 000 000 000/l f. WBC =3,0 x 1 000 000 000/L g. Hemoglobin > 90 g/l 8. Life expectancy = 12 weeks 9. Patients having received oral and written information and having provided written informed consent 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
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy for metastatic disease. (The patient may have received previous endocrine therapy or singeldrug Herceptin. Intrapleural or intrapericardial Novantrone is allowed.) 2. Recurrence =12 months after adjuvant anthracycline containing treatment and/or prior doxorubicin >300 mg/m2 or epirubicin > 540 mg/m2 3. Myocardial infarction within 6 months of planned inclusion 4. Symptomatic brain metastases 5. HER-2 positivity eligible for treatment with trastuzumab or ER positivity eligible for hormonal therapy 6. Allergy to anthracyclines 7. Uncontrolled infection 8. Other not radically treated malignancy 9. Other disease or condition contraindicating treatment or not allowing follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of Caelyx in elderly patients with metastatic or locally advanced disease. Treatment failure is defined as progression of disease (according to the RECIST criteria) or unacceptable toxicity leading to discontinuation of treatment or death.;Secondary Objective: To get information on safety, response rate, time to progression, survival, symptom control measured by patient assessment (modified ESAS symptom checklist), quality of life (EORTC QLQ-C30 and Breast Cancer Module QLQ-BR23) and analysis of treatment predictive factors in tumor tissue and blood and angiogenetic factors, proteomics and snp-analysis in serum/plasma and also to evaluate health resource utilization.;Primary end point(s): Time to treatment failure. Treatment failure is defined as progression of disease (according to the RECIST criteria) or unacceptable toxicity leading to discontinuation of treatment or death. | — |
Countries
Sweden
Outcome results
None listed