E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced or metastatic breast cancer |
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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 efficacy of the two study treatment groups |
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E.2.2 | Secondary objectives of the trial |
To compare the two study treatment groups with respect to:- - Tumour response rate, clinical benefit, time to response, duration of response, 6-months progression-free survival, overall survival - Toxicities due to treatment - Baseline and on-treatment serum ErbB1 and ErbB2 - Intra-tumoural expression of ErbB1, ErbB2 and other biomarkers - Quality of life. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Able to give signed informed consent - Histologically confirmed invasive breast cancer - Tumours either untested or negative for ErbB2 overexpression - Female aged >=18 years - Of non-childbearing potential, or if of childbearing potential then with negative serum pregnancy test at screening and agreement to follow protocol-defined methods of birth control - ECOG performance status of 0 or 1 - Measurable disease according to RECIST - Tumour tissue to be available to retrospectively compare tumour response with intra-tumoural expression of biomarkers - Prior neodjuvant or adjuvant treatment with an anthracycline- or anthracenedione-containing regimen is permitted as long as cumulative dose of named drugs has not been exceeded, and patient has recovered from all toxicities - Prior taxane as part of a neoadjuvant or adjuvant therapy is permitted as long as disease progression was >6 months after completion of this treatment - Radiotherapy prior to initiation of randomised treatment other than the sole site of measurable/assessable disease is allowed - Patients must not have >=Grade 2 peripheral neuropathy - Able to swallow and retain oral medication - Cardiac function must be within the normal range - Patients must complete all screening assessments |
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E.4 | Principal exclusion criteria |
- Pregnant or lactating - Received prior therapy for locally advanced or metastatic disease, or prior therapy with an ErbB1 and/or ErbB2 inhibitor in any setting - Bisphosphonate therapy for bone metastases initiated prior to start of randomised therapy is permitted; prophylactic bisphosphonates without bone disease are not permitted - Other malignancy unless disease-free for 5 years - Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel - Any concurrent condiction that would make study participation inappropriate, or any serious medical condition that might interefere with safety - Unresolved or unstable, serious toxicity from a prior investigational drug - Active or uncontrolled infection - Condition that prohibits understanding or rendering of informed consent - History of uncontrolled or symptomatic angina, arrythmias, or CHF - CNS metastases or leptomeningeal carcinomatosis - Concurrent anti-cancer therapy other than paclitaxel - Concurrent investigational agent or participation in another clinical trial - Prior investigational drug within 30 days or 5 half-lives (whichever is longer) of first dose of randomised therapy - Hypersensitivity or idiosyncrasy to drugs chemically related to GW572016 (or placebo), or excipients - Hypersensitivity to paclitaxel or its excipients. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to progression (TTP), defined as the interval between the date of randomisation and the earliest date of disease progression or death due to breast cancer (if sooner). |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
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 |