Phase II study of pegylated liposomal doxorubicin (Caelyxâ) in breast cancer patients with brain metastases and not candidate for an antiHER2 therapy - AROBASE

• Conditions: Breast Cancer Patients with Brain Metastases; MedDRA version: 9.1Level: PTClassification code 10055113Term: Breast cancer metastatic; MedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancer

• Registration Number: EUCTR2007-006790-81-FR
• Lead Sponsor: APREC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>-Duration of response<br>-Time to local tumor progression<br>-Progression-free survival<br>-Overall survival<br>-Toxicity and safety profile <br>;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.