ÉTUDE PILOTE OBSERVATIONNELLE CHEZ DES PATIENTES SOUFFRANT D’UN CANCER DU SEIN ET RECEVANT UNE CHIMIOTHÉRAPIE ÉMÉTISANTE TRAITÉES PAR UNE DOSE UNIQUE DE ALOXI® (PALONOSÉTRON) 0,25 MG ASSOCIÉE À UNE CORTICOTHÉRAPIE

Conditions: 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.
MedDRA version: 8.1Level: LLTClassification code 10056989Term: Nausea post chemotherapy

Registration Number: EUCTR2006-005803-33-FR

Lead Sponsor: THERABEL LUCIEN PHARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 250

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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