Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the study is to compare efficacy and tolerability of aprepitant versus dexamethasone in the prevention of delayed emesis induced by moderately emetogenic chemotherapy (cyclophosphamide plus anthracyclines) in breast cancer patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S. Maria Hospital, Terni
• Treatments: Aprepitant; BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant

Criteria

Inclusion Criteria:

• patients with breast cancer, receiving for the first time chemotherapy with cyclophosphamide + anthracyclines (FAC, FEC, AC, EC).

• patients over 18 years old and those who signed informed consent

• adequate contraception if premenopausal women

Every other anticancer drug in the first 24 hours will be administered after the end of cyclophosphamide plus anthracycline.

Exclusion Criteria:

• patients already submitted to chemotherapy

• patients receiving any chemotherapy on days 2-4 after treatment

• patients with concomitant 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 bleeding from peptic ulcer

• patients submitted to concomitant radiotherapy or submitted to radiotherapy in the 15 days before chemotherapy or planned to receive radiotherapy during the 8 days after chemotherapy

• patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy

• patients with nausea or vomiting in the 24 hours before chemotherapy

• patients receiving concomitant steroids, except when administered at physiologic doses

• patients receiving concomitant benzodiazepines, except when used for nocturnal sedation

• patients with WBC count <3000/mm3 or platelet count <70000/mm3

• patients who are pregnant or breast-feeding