E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast cancer; palpable and non-palpable tumours of the female breast. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 study is composed of two consecutive study steps. Only if Step 1 is successfully completed, Step 2 will be performed.
Primary Study Aims: •Step 1: Assessment and quantitative determination of PPIX fluorescence in palpable breast cancer tissues after oral administration of PD L 506 for implementation of the technical setting serving as prerequisite for Step 2. •Step 2: Assessment and quantitative determination of PPIX fluorescence in nonpalpable breast cancer tissue after oral administration of one of two different doses of PD L 506.
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E.2.2 | Secondary objectives of the trial |
•Examination of margins of the instantaneous tumour sections and the surgical cavity using PPIX fluorescence •Assessment of PPIX fluorescence of the sentinel lymph node (SLN) •Assessment of safety and tolerability of study medication
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Written informed consent has been signed prior to or at Visit 1 •Caucasian female postmenopausal patients •Patients with histologically confirmed primary palpable and nonpalpable breast cancer, respectively (depending on Step 1 or Step 2) sized up to 5 cm (T1 – T2)
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E.4 | Principal exclusion criteria |
•Use of photosensitising drugs e.g. tetracycline or hypericin within 14 days before tumour surgery •Diagnosis of porphyria •Suspicious lymphogenic metastases (cN1-3) •Acute or chronic hepatic diseases (levels of ASAT, ALAT and/or GT more than 2.5 times the upper normal limit) •Manifest renal diseases with renal dysfunction •Relevant cardiac disease •Patients with a body weight < 60 kg or > 90 kg •Preceding therapy of breast tumour under investigation •Patients with multiple attempts of hook-wire placement in preparation of surgery (only Step 2) •Known intolerance to study medication •Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent •Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
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E.5 End points |
E.5.1 | Primary end point(s) |
Both Steps: Mean PPIX fluorescence intensity in breast cancer tissue: •Qualitative assessment by the investigator: none/weak/strong •Histological evaluation of breast cancer tissue in comparison with non-malignant tissue with respect to PPIX fluorescence •Photo and video documentation •Determination of PPIX concentration by fluorescence spectrometry
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Fluorescence-guided resection |
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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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Same IMP in different dosage |
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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 | 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
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End of the trial = last visit of last patient undergoing the trial; please refer to study protocol. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |