E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lobular metastatic breast cancer |
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E.1.1.1 | Medical condition in easily understood language |
Lobular metastatic breast cancer |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
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 evaluate the feasibility to detect a change in tumor PD-L1 expression on a 89Zr-atezolizumab PET scan, before and after two carboplatin induction treatments. |
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E.2.2 | Secondary objectives of the trial |
• To assess the relation of 89Zr-atezolizumab tumor uptake (change) with response to carboplatin-atezolizumab.
• To determine the relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments (PD-L1 IHC, mRNA and other potential markers of interest in the setting of immune response such as macrophages).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. A patient must meet the inclusion criteria of the GELATO trial (see in attachment the protocol)
2. Able to give written informed consent and to comply with the ImaGelato protocol
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E.4 | Principal exclusion criteria |
1. Contra-indication for 89Zr-atezolizumab PET scan
2. Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤14 days prior to the first 89Zr-atezolizumab injection. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the first 89Zr-atezolizumab injection.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after two carboplatin induction treatments, defined as decline or increase of standardized uptake value (SUVpeak) of 30% or more, described as per lesion and per patient. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Data analysis will be performed on an ongoing basis after every patient. |
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E.5.2 | Secondary end point(s) |
• Relation of 89Zr-atezolizumab tumor uptake (at baseline, after carboplatin induction, and change between the two scans) per lesion and per patient with response to carboplatin-atezolizumab per lesion and per patient.
• Relation of 89Zr-atezolizumab tumor uptake at baseline and after carboplatin induction, with tumor biopsy assessments (PD-L1 IHC, mRNA and other potential markers of interest in the setting of immune response such as macrophages).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Data analysis will be performed on an ongoing basis after every patient. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |