Aprepitant in the prevention of delayed emesis induced by moderately emetogenic chemotherapy (cyclophosphamide + anthracycline) in breast cancer patients: a double-blind randomized study - Aprepitant in the prevention of delayed emesis

Conditions: patients with breast cancer receiving chemotherapy
MedDRA version: 9.1Level: SOCClassification code 10017947
MedDRA version: 9.1Level: HLTClassification code 10028817

Registration Number: EUCTR2008-001237-95-IT

Lead Sponsor: AZIENDA OSPEDALIERA S. MARIA DI TERNI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 800

Inclusion Criteria

-patients with breast cancer, receiving for the first time chemotherapy with cyclophosphamide + anthracycline. - patients over 18 years old and those who signed informed consent
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

- patients already submitted to chemotherapy - patients receiving chemotherapy on days 2-4 after cyclophosphamide plus anthracyclines - patients with other severe diseases or with predisposition to emesis such as intestinal obstruction, active peptic ulcer, hypercalcemia and brain metastases - contraindications to corticosteroids (i.e.; active peptic ulcer or previous blooding from peptic ulcer submitted to concomitant radiotherapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare efficacy and tolerability of aprepitant versus dexamethasone in the prevention of delayed emesis induced by moderately emetogenic chemotherapy (cyclophosphamide + anthracycline) in breast cancer patients;Secondary Objective: a) evaluation of the impact of quality of life of the two prophylactic antiemetics b) evaluation of the prognostic factors of delayed emesis in patients receiving a combination of aprepitant, palonosetron and dexamethasone for the prevention af acute emesis.;Primary end point(s): percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration

Secondary Outcome Measures