Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01298193
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2011-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Sample size We want to obtain an estimation of the percent of the patients that we assume won't have a response to the treatment against vomiting. Reviewing bibliography, we think that the percent is approximately 25%.
We are going to obtain an estimation of this percent with an accuracy of +/- 6%, with a bilateral confidence level of 95% bilateral. Whit all this premises it would be needed 201 patients.
Assuming a drop out of 5%, 212 patients will be included in the study.
A maximum of 212 patients will be included in the trial. It is anticipated that around 48 patients will enter the efficacy phase.
APPROXIMATE DURATION OF THE STUDY. Inclusion period: 18 months approximately. Estimated follow-up: December 2012 Estimated date of end of study: June 2013
We are going to obtain an estimation of this percent with an accuracy of +/- 6%, with a bilateral confidence level of 95% bilateral. Whit all this premises it would be needed 201 patients.
Assuming a drop out of 5%, 212 patients will be included in the study.
A maximum of 212 patients will be included in the trial. It is anticipated that around 48 patients will enter the efficacy phase.
APPROXIMATE DURATION OF THE STUDY. Inclusion period: 18 months approximately. Estimated follow-up: December 2012 Estimated date of end of study: June 2013
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-022689-29 | EUDRACT_NUMBER | None | View |