E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast cancer patients with liver metastases (no extrahepatic disease) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006202 |
E.1.2 | Term | Breast cancer stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Response rate Number of patients with complete or partial response in the liver (RECIST version 1.1)
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E.2.2 | Secondary objectives of the trial |
Time to a) Intrahepatic progression b) Extrahepatic progression c) Number of patients suitable for local therapy (radiofrequency) d) Survival e) Toxicity
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Correlation between biomarkers in tissue (hormones, HER2, and TOPO2) and blood (e.g. genes: mRNA and microRNA, SNP array profiles; proteins: p53, P1NP, P3NP, TIMP-1, IL-6, YKL-40, EGFR and VEGF) and metabolites and clinical endpoints (response, time to progression, survival) |
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E.3 | Principal inclusion criteria |
• Informed consent • Age > 18 years • Performance status 0-1; expected survival ≥ 3 months • Patient with histologically or cytologically confirmed adenocarcinoma of the breast • Liver metastases not suitable for local treatment • Extrahepatic disease should be excluded by PET-CT-scan. • No progression on treatment with capecitabine • Prior treatment with taxane (adjuvant or for metastatic disease) • Metastatic involvement < 70 % of the liver • Neutrophil granulocytes 1.5 x 109/l and thrombocytes 100 x 109/l • Bilirubine 2.0 x UNL (upper normal limit) • Creatinine-clearence 30 ml/min • INR < 2 • An angiography shows that intrahepatic treatment can be accomplished • The treatment is approved by ”Second Opinion udvalget”
If the patient is HER2-positive: • Baseline LVEF ≥ 50 % (MUGA or echocardiography)
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E.4 | Principal exclusion criteria |
• History of chemotherapy within the 4-week period prior to the start of trial medication • Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin • Previous treatment with oxaliplatin • Cytotoxic or experimental treatment within a 14 days period before start of trial medication • Current participation in other clinical trials • Any clinical symptoms suggesting peripheral neuropathy grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan must be conducted within 4 weeks before inclusion) • Other severe medical conditions e.g. severe cardiovascular disease or AMI < 1 year • Medical diseases or condition affecting the patients compliance with peroral study drug • Patients with uncontrolled infection • Pregnant or lactating women • Women capable of childbearing not using a sufficient non-hormonal method of birth control (spiral) • Patients who due to physiological, intelectual, cultural reasons, or lack of language capabilities, an unable to comply with the treatment concept or to place the patient at high risk from treatment related complications • Prior serious or unsuspected reaction to fluorpyrimidin therapy • Known prior hypersensitivity reactions any components used If the patient is HER2-positive: • Dyspnoe at rest due to complication of advanced malignancy e.g.lung metastases with lymphangitis or any other conditions necessitating supportive oxygen therapy
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E.5 End points |
E.5.1 | Primary end point(s) |
Response rate Number of patients with complete or partial response in the liver (RECIST version 1.1)
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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 | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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
| 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 | 3 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |