E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The prevention of acute or delayed Chemotherapy-Induced Nausea and Vomiting (CINV) by the combination of palonosetron 250 microgrammes and methylprednisolone 80 mg in patients receiving a first administration of a first line of emetogenic chemotherapy to treat their non metastatic breast cancer. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056989 |
E.1.2 | Term | Nausea post chemotherapy |
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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 |
to evaluate the therapeutic activity of palonosetron given as a single 250 micrograms IV administration, in combination with 80 mg of methylprednisolone given intravenously, in the prevention of acute or delayed nausea and vomiting episodes in “naïve” patients who are receiving a first cycle of a first line of emetogenic chemotherapy for their non metastatic breast cancer. |
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E.2.2 | Secondary objectives of the trial |
to study the tolerability of palonosetron used in combination with methylprednisolone in these patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age > 18 years - Female - Patients with non-metastatic breast cancer (cytologically or histologically confirmed) and who are to receive a 1st course of adjuvant chemotherapy on D1 - Patients must receive one of the three following chemotherapy regimens, all of those being fully administrated at Day 1 (D1) every 3 (or 4) weeks (there shall not be any chemotherapy administration in the meantime between V1 and V2): a) 5-FU (500 mg/m2) + Epirubicin (75 or 100 mg/m2) + Cyclophosphamide (500 mg/m² ): FEC (75 or 100) b) Epirubicin (75 mg/m²) + Cyclophosphamide (> 500 mg/m²): EC c) Adriamycin (40 or 50 mg/m²) + Cyclophosphamide (> 500 mg/m²): AC - Patients who have given their informed consent in writing - Karnofsky performance status > 60
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E.4 | Principal exclusion criteria |
- Pregnant or breastfeeding female - Vomiting events (or retching) or nausea on the day of inclusion or in the 24 hours preceding the day of inclusion - Female suffering from alcoholism or drug dependency - Patients included in a clinical trial in the previous month - Patients whose language ability or ability to understand could negatively affect the proper completion of the self-evaluation diary. - Prior treatment with palonosetron - Contraindication to methylprednisolone (SPC of SOLUMEDROL®, Appendices § 14.7) - An ongoing cancer chemotherapy other than that which is allowed in the inclusion criteria of the protocol - Administration in the 24 hours prior to inclusion or on the day of the inclusion of any of the following medicinal products: a) Other ‘setrons’ (ondansetron, granisetron, tropisetron, dolasetron) b) Metoclopramide, phenothiazine (perphenazine), scopolamine, diphenhydramine, chlorphenamine, benzodiazepines (except for temazepam or triazolam used as a single dose as a hypnotic), haloperidol, droperidol, tetrahydrocannabinol c) Corticosteroid therapy (except for topical and inhaled preparations, which are allowed) - Hypersensitivity to the active substance or any of the excipients |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the evaluation of nausea and vomiting using the self-evaluation diary filled out by the patient: - Acute CINV (Chemotherapy-Induced Nausea and Vomiting) (first 24 hours) - Delayed CINV (D2, D3, D4 and D5).
The primary evaluation measure is the percentage of complete responses, defined by the percentage of patients who have: - Not experienced an emetic episode - And who have not received antiemetic rescue medication (at investigator’s discretion).
An emetic episode is defined as: - A single vomiting event - A sequence of vomiting events separated by less than one minute - Any number of unproductive retching events lasting more than 5 minutes - Any number of unproductive retching events lasting less than 5 minutes and vomiting separated by less than one minute.
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |