E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease). |
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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 |
The primary objective of this study is to evaluate the cardiac safety profile of first line Caelyx chemotherapy in metastatic breast cancer patients with prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m2 and <360mg/m2 doxorubicin or >430mg/m2 and <650mg/m2 epirubicin). |
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E.2.2 | Secondary objectives of the trial |
- detect the clinical response - measure the progression-free survival - evaluate the overall safety and tolerability of Caelyx therapy
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease).
- Prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m2 and <360mg/m2 doxorubicin or >430mg/m2 and <650mg/m2 epirubicin).
- >18 years of age.
- Documented measurable and/or evaluable metastatic breast cancer by appropriate radiological imaging (CT scan and/or MRI).
- Performance status of at least 60% (Karnofsky index) and a life expectancy of at least 12 weeks.
- Left ventricular ejection fraction > 50%.
- Normal organ function, except if abnormal due to tumor involvement.
Adequate bone marrow function as indicated: Platelets > 100,000/mm3 Hemoglobin > 9 g/dL Neutrophils > 1,500/mm3
Adequate renal function as indicated by: Serum Creatinine <1.5 x the upper limit of normal
Adequate liver function, as indicated by: Bilirubin and AST or ALT < 2 times upper limit of normal (< 4 times upper limit of normal when related to primary disease)
- Subjects must be capable to demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
- Subjects must understand and be able to adhere to the dosing and visit schedules.
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E.4 | Principal exclusion criteria |
- Patient is pregnant or is breast feeding.
- Patients with moderate or severe heart failure (NYHA class III/IV).
- Patient is hypersensitive to anthracycline therapy or has a history of severe hypersensitivity reactions to products containing Cremophor EL (e.g., cyclosporin for injection concentrate and teniposide for injection concentrate).
- Age < 18 years.
- Prior chemotherapy for metastatic disease.
- Clinically significant hepatic disease (except liver metastases of primary disease).
- Patient has uncontrolled bacterial, viral, or fungal infection.
- Radiotherapy in the last 4 weeks or prior radiation therapy to more than one-third of the hemopoietic sites.
- Any other currently known malignancy or pre-malignant lesions or any history of other malignancy within the past five years (except non-melanoma skin cancer and surgically cured cervical cancer).
- Patient has symptomatic metastasis to the brain.
- Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
- Documented HIV infection.
- Any condition (medical, social, psychological) which would prevent adequate follow-up.
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E.5 End points |
E.5.1 | Primary end point(s) |
Cardiac event as defined as a decrease in LVEF of >20 points from baseline if the resting LVEF remains in the normal range, or a decrease of >10 points if the LVEF became abnormal (lower than the institutional lower limit of normal). |
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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 | Information not present in EudraCT |
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) | 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 | 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) | 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.8.5 | 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 | 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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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 | |