Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
This is a prospective, multicenter, open label, non-comparative trial in Spain.
The primary objective of this study is to determine the complete response, defined as no
vomiting and no use of rescue treatment, in women with early-stage breast cancer treated with
one cycle of Docetaxel-Cyclophosphamide and active therapy for the prevention of CINV
(Chemotherapy-induced nausea and vomiting) day 1, 5-hydroxytryptamine 3 (5-HT3) antagonist
plus 3 days of dexamethasone. A second step (efficacy phase) is designed to examine the
efficacy and tolerability of aprepitant in the second cycle among patients who failed to the
previous CINV prevention treatment.
The study will focus on early-stage chemonaive breast cancer patients receiving
docetaxel-cyclophosphamide and a 5-HT3 antagonist plus dexamethasone for the CINV prevention.
The CINV incidence in those patients will be evaluated on the first cycle. All refractory
patients, will be asked to participate in the second phase, where aprepitant on days 1, 2 and
3 will be added to their antiemetic regimen.
Assuming a drop out of 5%, 212 patients will be included in the study. It is anticipated that
around 48 patients will enter the efficacy phase.
The duration of the study, from first patient visit to last patient visit will be
approximately 21 months.