E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To compare the safety and efficacy of two docetaxel dosing schedules: Taxotere 50mg/m2 every 2 weeks vs. Taxotere 100mg/m2 every 3 weeks
Primary endpoint: to compare time to treatment failure (TTF) in the two treatment arms. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoint: to compare the toxicity profile and response rate according to WHO criteria in the two treatment arms |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Histologically confirmed breast cancer • Metastatic disease confirmed by x-ray/ CT/ US/ bone scan, biopsy is optional • Female > 18 years of age • ECOG performance status under or equal to 2 • If patient has received taxanes as adjuvant therapy, a minimum of 6 months has passed since the end of taxane treatment prior randomization · Patient has not received taxanes for metastatic disease. Other chemotherapy for metastatic disease is allowed. • Prior hormonal treatment regimens are allowed • At least one measurable lesion by CT/MRI/US. if only bone metastases present, at least one of them have to be lytic. • Adequate hematology: - neutrophils > 1.5 x 109/l - platelets > 100 x 109/l - Hb > 100 g/l (after transfusion when needed) • Adequate renal function: serum creatinine under or equal to 1.25 x upper normal limit • Adequate liver function - bilirubin under or equal to upper normal limit (except if liver metastasis present, 1.25 x UNL allowed) - ASAT/ALAT under or equal to 1.5 x upper normal limit - alkaline phosphatase under or ewual to 5 x upper normal limit; patients with bone metastases who have alkaline phosphatase over or equal to 5 x upper normal limit are allowed to participate if they have normal liver function and no hepatic lesions) • Consent form signed and dated before randomisation • Able to comply with the scheduled follow-up and with the management of toxicities |
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E.4 | Principal exclusion criteria |
• Patients with pre-existing fluid retention such as pleural effusion, pericardial effusion and ascites are not excluded from the study but should be monitored closely for any deterioration. • Concurrent severe and/or uncontrolled co-morbid medical condition such as uncontrolled infection, uncontrolled hypertension, ischemic heart disease, congestive heart failure, pulmonary embolism or myocardial infarction within previous 12 months, unstable diabetes or other reason preventing use of corticosteroids, autoimmune disease. • History of previous or concurrent malignancy within the previous 5 years except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin • Pregnant or lactating women (or potentially fertile women not using adequate contraception)• Peripheral neuropathy ≥ grade 2, unless related to mechanical etiology • Concurrent use of corticosteroids unless chronic treatment (i.e. initiated > 6 months prior to study entry) at low doses (under or equal to 20 mg methylprednisolone or equivalent) • History of allergic reaction to docetaxel or other drugs containing the excipient TWEEN 80®. • Concomitant administration of any other experimental drug under investigation: concurrent treatment with any other anti-cancer therapy • Patients who cannot be regularly followed up for psychological, social, family or geographic reasons. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the safety and efficacy of two docetaxel dosing schedules: Taxotere 50mg/m2 every 2 weeks vs. Taxotere 100mg/m2 every 3 weeks |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Taxotere in two different schedules and doses |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |