E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with breast carcinoma and liver-dominant metastasis |
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E.1.1.1 | Medical condition in easily understood language |
Patients with breast carcinoma and liver-dominant metastasis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
To evaluate the efficacy of intra-arterial hepatic doxorubicin therapy in Metastatic Breast Cancer. The primary objective of this study is to determine the safety, feasibility, and tolerance of intra-arterial doxorubicin-loaded microsphere treatment. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective will be to evaluate the response rate , time to progression and survival. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with biopsy proven liver dominant ( over 50% volume) metastasis of breast carcinoma
• Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST criteria)
• Hematologic function: ANC 1.5 x 109/L, platelets 75 x109/L, INR <1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to intervention
• Adequate liver function as measured by: Total bilirubin ≤ 2.0 mg/dl
• Adequate renal function (creatinine ≤ 2.3 mg/dl)
• written informed consent
• over 18 years of age
• eligible for treatment
• non pregnant
• using an acceptable contraceptive if premenopausal.
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E.4 | Principal exclusion criteria |
• contraindication to angiographic and selective visceral catheterization
• significant extrahepatic disease representing an eminent life-threatening outcome : more than 75% of hepatic parenchymal involvement
• severe liver dysfunction
• and severe cardiac comorbidities.
• Active bacterial, viral or fungal infection within 72 hours of study entry
• Women who are pregnant or breast feeding
ECOG Performance Status score of >3
Life expectancy of < 3 months
• Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated
• Any contraindication for hepatic embolization procedures:
- Large shunt as determined by the investigator (pretesting with TcMMA not required)
- Severe atheromatosis vascular disease that precludes arterial cannulization
- Hepatofugal blood flow
- Main portal vein occlusion (e.g. thrombus or tumor)
• Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation
• Patients with prior contraindications for the use of doxorubicin
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E.5 End points |
E.5.1 | Primary end point(s) |
Technical feasibility of the treatment protocol, including: adequate pain relief during the procedure, the loading of beads, angiographic success and procedure-related toxicity ( defined as procedure related complications that makes hospitalisation longer than 48 hours post-procedure necessary. Proportion of patients completing scheduled treatment plan.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 day, 30 days, every three months |
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E.5.2 | Secondary end point(s) |
Response rate ( according to RECIST), time to progression, and overall survival . |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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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5-year survival of all ten patients, earlier when all patients will have died |
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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 |