E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
histologically proven early breast cancer requiring adjuvant chemotherapy according to the treating physician (lymph node positive or other features of high risk according to St-Gallen criteria). 16 evaluable elderly patients (65 y or older) with high risk early breast cancer requiring adjuvant chemotherapy.
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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 |
We would like to investigate the effect of Caelyx on cardiac function using three new methods to assess cardiac function, namely (i) SRI (strain rate imaging), (ii) BNP and (iii) Troponin I. Secondarily relate these findings to the classical EF measurement. The early detection of cardiac dysfunction might allow switching over from adriamycin to caelyx in an earlier stage, thus preventing development of significant cardiac failure. |
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E.2.2 | Secondary objectives of the trial |
To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients must meet all of the following inclusion criteria in order to be eligible for participation in this study: • histologically proven early breast cancer requiring adjuvant chemotherapy according to the treating physician (lymph node positive or other features of high risk according to St-Gallen criteria). • Age 65 years • Normal cardiac function (assessment of LVEF by MUGA scan or echocardiography above the lower limit of normal for the institution). • Performance status 0 to 2 (WHO scale) • The determination of ER and PgR is mandatory (immunohistochemical methods required; ER and/or PgR positivity is defined as > 1% of positive cells). Also determination of Her2neu is mandatory, either by immunohistochemistry or by FISH • Adequate organ function (as defined by neutrophils 1.5 x109/L, Platelets 100 x 109/L, Hemoglobin 10 g/dl, total bilirubin 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) 1.5 UNL, alkaline phosphatase 2.5 UNL, creatinine 1.5 mg/dl (150 µmol/L) • Complete staging work-up within 2 months prior to registration. All patients will have bilateral mammography, chest X-ray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. In case of positive bone scan suspicious for metastases, bone X-ray (or bone CT-scan on spinal hot spots) is mandatory to rule out the possibility of metastatic disease. Other tests may be performed as clinically indicated. • Patients must be accessible for treatment and follow-up. • absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial • before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
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E.4 | Principal exclusion criteria |
• Metastatic disease (M1) • prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of immunotherapy) • prior radiation therapy for breast cancer. • pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria. • serious illness or medical condition: a/ congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrythmias b/ history of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent. c/ active uncontrolled infection d/ active peptic ulcer, unstable diabetes. • past (less than 5 years) or current history of other neoplasm except for curatively treated basal cell skin cancer or in situ carcinoma of the cervix. • concurrent treatment with hormonal replacement therapy: this treatment should be stopped at least 15 days before study entry • concurrent treatment with other experimental drugs. No participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. • concurrent treatment with any other anti-cancer therapy.
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E.5 End points |
E.5.1 | Primary end point(s) |
Is SRI decreased after 6 cycles of Caelyx-Cyclophophamide ? |
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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 | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Information not present in EudraCT |
E.8.1.1 | Randomised | Yes |
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) | Yes |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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although the chemotherapy ends after 18 weeks, regular follow-up with cardiac check-up (SRI = special echography of the heart, blood test) is foreseen at 6 months,n 1 year and 3 years. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |