E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or refractory infammatory breast cancer (IBC) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021974 |
E.1.2 | Term | Inflammatory breast cancer |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of objective response rate (complete response + partial response) to lapatinib treatment in patients with relapsed or refractory IBC whose tumours overexpress ErbB2 |
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E.2.2 | Secondary objectives of the trial |
- Evaluate other measures of anti-tumour activity - Assess safety and tolerability of study treatment - Investigate pharmacodynamic effects of study treatment on intracellular biomarkers - Assess the effects of study treatment on proteomic profile and blood levels of extracellular domains of the ErbB1 and ErbB2 receptors - To examine use of FDG-PET as an early predictor of response to study treatment - Pharmacogenetic investigation/s |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A sub-study exists to explore early disease response utilizing FDG-PET imaging. This is purely for those sites and subjects who are interested in taking part. |
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E.3 | Principal inclusion criteria |
- Histologically confirmed breast carcinoma with clinical diagnosis of IBC - Documented disease progression or relapse following treatment, which must have included a taxane and anthracycline-containing regimen in the adjuvant or metastatic setting (30 patients) plus trastuzumab (90 patinets) - Tumour that overexpresses ErbB2 as 3+ by IHC or FISH-positive. The ErbB2 expression status must be documented prior to dosing. - Must have life expectancy of at least 12 weeks - Tumour to be accessible for biopsy - Measureable disease by RECIST or clinically evaluable skin disease - Male or female at least 18 years of age - Female patients must either be of non-childbearing potential, or if of childbearing potential to have negative serum pregnancy test at screening and to agree to a protocol-specified method of contraception during participation in the study - Able to swallow and retain oral medication - ECOG performance status 0-2 - Recovered or stabilised from effects of previous chemotherapy, surgery or radiotherapy - Have adequate bone marrow function, and renal and hepatic function - Have left ventricular ejection fraction greater than or equal to 50%, or above lower limit of normal for the institution - Provide written informed consent
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E.4 | Principal exclusion criteria |
- Female who is pregnant or lactating - Patient who has malabsorption syndrome, disease affecting GI function, or resection of the stomach or small bowel - Evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. Patients with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants. - Considered medically unfit by the investigator - Has known hypersensitivity reaction or idiosyncrasy to drugs chemically-related to the IMP - Received treatment with any investigational drug in previous 4 weeks - Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy within the past 14 days (except mitomycin C within past 6 weeks) - Currently receiving amiodarone or within 6 months prior to screening - Currently receiving oral steroid treatment, or any other protocol-specified prohibited medication - Has condition/s which will not permit compliance with the protocol - Has Class II-IV heart failure (by NYHA classification system) - Has a clinically significant ECG abnormality - Has inadequate venous access for protocol-related blood sampling. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of Objective Response Rate (defined as Complete Response plus Partial Response) |
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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 | 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 | Yes |
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) | 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 | 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) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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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Last subject, last visit. |
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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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |