Breast Cancer Patients with Brain Metastases MedDRA version: 9.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Trade Name: CAELIX
Product Name: CAELIX
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Pegylated liposomal Doxorubicin
Concentration unit: mg/m2 milligram(s)/square m
Sponsors
APREC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically proven breast carcinoma with brain and/or CNS metastases, -Minor neurological signs and symptoms, -No active extra-CNS metastases, -No contraindication for Caelyx? treatment, -Age > 18 years, -World Health Organization (WHO) performance status (PS) = 2, -No previous radiotherapy of the brain, -Life expectancy sup 3 months, -Prior anthracyline-based treatment is allowed. Cumulative doses have to be less than 360 mg/m² for doxorubicin, and 600 mg/m² for epirubicin. -Anthracyclines have to be stopped for at least 612 months before study entry, -Adequate laboratory tests: hemoglobin (Hb) sup 10 g/dL, neutrophils sup 1.5 x 109/L, platelets sup 100 x 109/L, creatinine inf 1.5 upper limit of normal (ULN), bilirubin sup 1.5 ULN, alkaline phosphatases sup1.5 ULN, transaminases (ASAT/ALAT) and GGT inf 1.5 ULN except in case of liver metastases (inf normal value x 4), -Patient should be recover to grade I or baseline of any toxicity due to previous anticancer therapy,, -Satisfying cardiac function: NYHA stage inf 2 and left ventricular ejection fraction (LVEF) sup 50% at baseline, -Adequate contraception in premenopausal women, -Written informed consent. -The patient must be affiliated to a Social Security regime or be a beneficiary of such a regime Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: -Disease progression during or within 6 months after anthracycline-based chemotherapy, -Medical history of severe or uncontrolled cardiac disease: NYHA stage ? 3, myocardial infarct within the last 6 months, unstable angina, rhythm disorders requiring treatment, -UncontrolledSymptomatic brain metastases and /or carcinomatous meningitis under symptomatic corrective treatment, -Trastuzumab, Bevcitabin or lapatinib therapy within 4 weeks before inclusion, -Hormonal treatment within the last 4 weeks -Trastuzumab therapy within 24 weeks before inclusion, -Severe or uncontrolled infection, or other severe concomitant disease impeding the administration of study drug, -Positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV) or C virus (HBC), -Pregnant woman or breast-feeding period, -Previous history of cancer within last 5 years except treated in situ uterine cervix carcinoma and basal-cell carcinoma of the skin correctly treated, -Disability to be followed because of geographic, social or psychological reasons, -Hypersensitivity to doxorubicin and/or to excipients, or contreindications -Participation to any clinical trials within the last 30 days, -Active extra-CNS metastases, -Patient with previous EPP syndrome >grade 1, -Local prior therapy of Brain metastasis, -Anticancer therapy within the last 2 weeks before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess and evaluate the local clinical and radiological local response rate according to RECIST criteria.;Secondary Objective: Secondary objectives were the evaluation of: -Duration of response -Time to local tumor progression -Progression-free survival -Overall survival -Toxicity and safety profile ;Primary end point(s): The primary endpoint of study is the local response rate that will be reported for all patients enrolled according to the intention-to-treat (ITT) principle, and for assessable and per protocol patients with 95% confidence interval (95%CI). The tumor response will be individually assessed according to the RECIST criteria. | — |
Countries
France
Outcome results
None listed