E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary breast cancer T1-3 N0-1 M0 Histologically-confirmed HER 2 positive |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
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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 estimate the effect of GW572016 compared with placebo on the change in tumour cell proliferation in breast cancer tissue at baseline by core biopsy and after 3 or 9 weeks on the surgical specimen. |
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E.2.2 | Secondary objectives of the trial |
percentage of pCR; objective response rate; percent change in Epidermal growth factor receptor EGFR or HER-1 and HER-2; apoptosis ; additional markers of cell activation status; plasma concentrations of GW572016; incidence and severity of adverse event |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Provision of written and signed informed consent; 2. Female, aged 18 years or older; 3. Primary breast cancer T1-3 N0-1 M0 4. Histologically-confirmed HER 2 positive ErbB-2 3 , regardless of the FISH results, or 2 with FISH positive . 5. Bone marrow, renal, and hepatic function must meet the following criteria WBC 8805; 3.0 x 109/L Granulocyte count 1.500 x 109/L Platelet count 100 x 109/L Serum creatinine 120 mmol/L 1.35 mg/dl Serum bilirubin within normal/reference range AST/ALT within 1.5 x upper normal limit 6. Cardiac ejection fraction within the institutional range of normal as measured by echocardiography or MUGA. 7. Performance status 0 SWOG . |
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E.4 | Principal exclusion criteria |
1. Previous treatment for breast cancer including chemotherapy and endocrine therapy. 2. Known severe hypersensitivity to GW572016 or any of the excipients of this product; 3. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 4. As judged by the investigator, any evidence of severe or uncontrolled systemic disease e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease that would prevent subjects from undergoing any of the treatment options or would prevent prolonged follow-up. 5. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study. 6. Pregnancy or breast feeding women of child-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment and practice acceptable methods of birth control to prevent pregnancy. . 7. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. 8. Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease e.g., Crohn s, ulcerative colitis . |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 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
| |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |