E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced and/or metastatic breast cancer, not amenable to surgery. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | 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 |
To evaluate the safety and efficacy of Caelyx in elderly patients with metastatic or locally advanced disease. Treatment failure is defined as progression of disease (according to the RECIST criteria) or unacceptable toxicity leading to discontinuation of treatment or death. |
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E.2.2 | Secondary objectives of the trial |
To get information on safety, response rate, time to progression, survival, symptom control measured by patient assessment (modified ESAS symptom checklist), quality of life (EORTC QLQ-C30 and Breast Cancer Module QLQ-BR23) and analysis of treatment predictive factors in tumor tissue and blood and angiogenetic factors, proteomics and snp-analysis in serum/plasma and also to evaluate health resource utilization. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Female patients with histologic or cytologic diagnosis of breast cancer that is inoperable locally advanced or metastatic. 2. Age ≥ 65 years. 3. WHO Performance Status 0 - 2 4. Measurable disease in accordance with RECIST criteria. Patients with bone metastasis can also be included but will be evaluated according to WHO criteria. Patients with non-measurable disease can also be included. 5. LVEF ≥50% verified by UCG, no clinical signs of heart disease 6. Normal organ function, except due to disease involvement, however maximum deviation: a. Creatinine ≤ 1.5 x upper normal limit b. Bilirubin ≤ 2 x upper normal limit c. ALAT and/or ASAT ≤ 3 x upper normal limit. In case of liver metastases, ALAT and/or ASAT ≤ 5 x upper normal limit. 7. Adequate bone marrow function, i.e.: d. Platelets ≥100 x 1 000 000 000/L e. Neutrophils ≥1,5 x 1 000 000 000/l f. WBC ≥3,0 x 1 000 000 000/L g. Hemoglobin > 90 g/l 8. Life expectancy ≥ 12 weeks 9. Patients having received oral and written information and having provided written informed consent
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E.4 | Principal exclusion criteria |
1. Previous chemotherapy for metastatic disease. (The patient may have received previous endocrine therapy or singeldrug Herceptin. Intrapleural or intrapericardial Novantrone is allowed.) 2. Recurrence ≤12 months after adjuvant anthracycline containing treatment and/or prior doxorubicin >300 mg/m2 or epirubicin > 540 mg/m2 3. Myocardial infarction within 6 months of planned inclusion 4. Symptomatic brain metastases 5. HER-2 positivity eligible for treatment with trastuzumab or ER positivity eligible for hormonal therapy 6. Allergy to anthracyclines 7. Uncontrolled infection 8. Other not radically treated malignancy 9. Other disease or condition contraindicating treatment or not allowing follow up
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to treatment failure. Treatment failure is defined as progression of disease (according to the RECIST criteria) or unacceptable toxicity leading to discontinuation of treatment or death. |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 7 |
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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The study will end, and accordingly the follow-up will stop when the last patient has stopped treatment. |
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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 | |
E.8.9.1 | In the Member State concerned days | |