E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
|
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 evaluate the acquisition of the HER2/neu overexpression on CTC in patients with advanced breast cancer |
|
E.2.2 | Secondary objectives of the trial |
To evaluate then correlation of acquisition of HER-2/neu overexpression on CTCs and clinical outcome |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with Metastatic breast cancer (MBC) are considerate eligible. - For the evaluation of concordance between the primary tumour and CTCs, we will be considered eligible patients with MBC, untreated for metastatic disease, with HER-2/neu overexpressed or not on primary tumour, before to start any treatment. - For the evaluation of acquisition of HER-2/neu overexpression, will be considered eligible patients with MBC and HER-2/neu negative on primary tumour, pre-treated with at least one line of chemotherapy. Patients evaluated in the first part of the study, with HER-2/neu negative on primary tumour evaluation and on CTCs, will be valuable for the second part of the study. - For the evaluation of efficacy of trastuzumab-based therapy, will be considered eligible those patients with HER-2/neu absent on primary tumour, that acquired HER-2/neu overexpression on CTCs |
|
E.4 | Principal exclusion criteria |
- Any psychiatric disorder that would impair the understanding and giving of informed consent. - Male patients. - Non evaluable lesions - Pregnant or lactating patients. - History of atrial ventricular arrhythmia, congestive heart failure or angina pectoris, even if medically controlled; uncontrolled hypertension; history of 2nd or 3rd degree heart blocks. - Any history of a second neoplasm except for curatively treated non melanoma skin cancer or carcinoma in situ of the cervix. - Concomitant treatment with other anticancer drugs or other experimental drug. - Patients with not adequate haematological, hepatic and renal function - other serious illness or medical condition |
|
E.5 End points |
E.5.1 | Primary end point(s) |
prevalence of patients with the same HER-2/neu expression between the primary tumour and CTCs, and acquisition of HER-2 overexpression. |
|
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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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 | 3 |
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 |