E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast Cancer Patients with Brain Metastases |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10055113 |
E.1.2 | Term | Breast cancer metastatic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027475 |
E.1.2 | Term | Metastatic breast cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess and evaluate the local clinical and radiological local response rate according to RECIST criteria. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives were the evaluation of: -Duration of response -Time to local tumor progression -Progression-free survival -Overall survival -Toxicity and safety profile
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |