Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With the Docetaxel-Cyclophosphamide Regimen in Early Breast Cancer Patients
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-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 chemonaïve 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Open Label, Non-comparative Trial to Determine the Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With the Docetaxel-Cyclophosphamide Regimen in Early Breast Cancer Patients|
- To determine the incidence of complete response, defined as no vomiting and no use of rescue treatment within the first cycle of Docetaxel-Cyclophosphamide for the treatment of early-stage breast cancer patients [ Time Frame: Up to 21 days after cycle 1 of chemoteraphy treatment ] [ Designated as safety issue: No ]
- To evaluate in cycle 2 the efficacy of aprepitant (days 1, 2 and 3) as secondary prevention in patients without complete response in cycle 1 [ Time Frame: Up to 21 days after cycle 2 of chemoteraphy treatment ] [ Designated as safety issue: No ]
- To evaluate the toxicity of study drug (cycle 2) in those patients. [ Time Frame: Up to 30 days after completion of or discontinuation from the study. ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Observational phase (first cycle):
Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).
• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Efficacy phase (second cycle):
Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg).
Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg).
Efficacy phase (second cycle)
|Corporación Sanitaria Parc Taulí|
|Sabadell, Barcelona, Spain, 08208|
|Hospital Universitario Principe de Asturias|
|Alcalá de Henares, Madrid, Spain|
|Fundación Hospital de Alcorcón|
|Alcorcón, Madrid, Spain, 28922|
|Centro Oncológico de Galicia|
|A Coruña, Spain, 15009|
|Complejo Hospitalario Universitario A Coruña|
|A Coruña, Spain, 15006|
|Hospital del Mar|
|Barcelona, Spain, 08003|
|Hospital Clinic i Provincial|
|Barcelona, Spain, 08036|
|Complejo Hospitalario de Jaén|
|Jaén, Spain, 23007|
|Hospital Universitario Arnau de Vilanova|
|Complexo Hospitalario Xeral Calde|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hospital Arnau de Vilanova|
|Valencia, Spain, 46015|
|Hospital Clínico Universitario Lozano Blesa|
|Zaragoza, Spain, 50009|
|Principal Investigator:||Antonio Llombart, MD||Hospital Universitario Arnau de Vilanova|
|Principal Investigator:||Carlos Jara, MD||Fundación Hospital Alcorcón|