E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with HER-2/neu 1+ or 2+/FISH negative expressing advanced or metastatic breast cancer (stage IIIb/IV) progressing after endocrine treatment. |
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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 |
The primary objective of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer (stage IIIb/IV) which has progressed after endocrine therapy. HER-2/neu 2+ patients must have a negative FISH test. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are the evaluation of safety data and determination of further efficacy data in terms of time to progression (TTP), duration of response and clinical benefit. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a.Female gender, aged 18 or older, with life expectancy of at least 6 months; b.Negative pregnancy test at screening (and not more than 72 hours prior to the first ertumaxomab infusion).For women of childbearing potential, patients must agree to use adequate contraception during the study; c.Histologic diagnosis of adenocarcinoma originating in the breast; d.Evidence that the cancer is locally advanced (stage IIIb) or metastatic (stage IV) and not curable by local measures i.e. surgery, radiation; e. Measurable disease, defined as at least one lesion that is measurable in one dimension (Response Evaluation Criteria in Solid Tumors [RECIST criteria]); f. HER-2/neu expression 1+ or 2+ (confirmed by Dako Hercep Test). HER-2/neu 2+ patients must have a negative FISH test; g. Hormone Receptors (ERs) positive and /or Progesterone Receptors (PRs) positive; h. Prior adequate endocrine therapy for advanced or metastatic disease; i. Disease progression during or after endocrine therapy; l. No prior treatment with mouse or rat antibodies;m. Adeguate hematological, liver, kidney function; n. Creatinine < 1.5 x ULN or clearance > 60 mL/min; o. Adequate recovery from prior systemic therapy. |
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E.4 | Principal exclusion criteria |
a. Women who are pregnant or breast feeding; b. Known Human Immunodeficiency Virus (HIV) Infection; c. Any history or symptoms indicative of brain or central nervous system metastases; d. Presence of Autoimmune diseases; e. Any concurrent chemotherapy, hormonal therapy, immunotherapy or corticoid therapy; f. Any concurrent investigational treatment for advanced or metastatic disease; g. History of relevant cardiovascular disease as follows: left ventricular ejection fraction (LVEF) below the institution's lower limit of normal, based on echocardiography (ECG) at rest - uncontrolled or symptomatic congestive heart failure (New York Heart Association (NYHA)>2 - Uncontrolled or symptomatic arythmia - Uncontrolled angina pectoris - Myocardial infarction during the last 2 years. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is objective response rate (ORR) to ertumaxomab (best response during the course of the study) defined as the proportion of patients with complete response (CR) or partial response (PR) according to RECIST relative to the total analysis set of evaluable patients. Only patients having received at least two ertumaxomab infusions will be evaluable |
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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 | 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 | 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 | 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
| 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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |