E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027475 |
E.1.2 | Term | Metastatic breast cancer |
E.1.2 | System Organ Class | 100000004864 |
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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 |
Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1 |
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E.2.2 | Secondary objectives of the trial |
Progression free survival Overall survival toxicity. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histological or cytological confirmed adenocarcinoma of the breast MBC with ≥ 4 TOP1 genes in the primary tumour. Age › 18 Performance status 0-2 Locally advanced or metastatic disease HER2 negative disease Measurable disease by RECIST 1.1 Maximum 4 prior chemotherapy regiments for locally advanced or metastatic disease Neutrophil count (ANC) ≥ 1,5 x 10⁹/l and platelet count ≥ 100 x 10⁹/l Serum bilirubin ≤ 1.5 x ULN Serum transaminases ≤ 2.5 x ULN Written informed consent
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E.4 | Principal exclusion criteria |
Other present or previous malignancy except curatively treated cervical cancer stage I or non-melanotic skin cancer Cytotoxic or experimental treatment 2 weeks prior to inclusion Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory. Fertile patients not willing to use IUD as an acceptable and safe method of contraception CNS metastasis Allergy to the ingredients of the study medication. Patients who due to linguistic, culturel or incelectual reasons do not understand the protocol information Any condition or therapy that in the opinion of the investigator will put the patient at risk Patients with ongoing infections or other serious concomitant medical conditions that could interfere with the treatment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Progression free survival Overall survival toxicity. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
PFS: from first treatment date to progression or death Overall Survival: from first treatment date to death of any cause Toxicity: at every clinical control |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 6 |
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 | 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 |