Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-05 @ 1:45 PM
Study NCT ID:
NCT01953003
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2013-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Sponsor:
Pierre Fabre Medicament
Organization:
Study Overview
Official Title:
A Multicenter, Randomised, Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously
Status:
COMPLETED
Status Verified Date:
2019-01
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:
Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of patients do not respond to this treatment and those who respond eventually develop clinical resistance.
The antitumour activity of vinflunine has been demonstrated in patients with breast cancer after exposure to anthracycline and to taxane.
Vinflunine plus capecitabine has been shown to be a feasible combination for patients previously treated with an anthracycline and a taxane. Each drug in combination can be administered at efficacious doses.
This population has few therapeutic options with established clinical benefit. The development of a new regimen and potential new standard of care for this group is important.
* Primary objective:
• to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival.
* Secondary objectives:
* to evaluate the response rate, the time to response and the duration of response in both arms
* to compare the disease control rate between arms
* to evaluate the duration of disease control in both arms
* to evaluate the overall survival in both arms
* to evaluate safety
Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of 334 patients with advanced breast cancer who have previously been treated with an anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus capecitabine (Arm A) or capecitabine alone (Arm B).
The antitumour activity of vinflunine has been demonstrated in patients with breast cancer after exposure to anthracycline and to taxane.
Vinflunine plus capecitabine has been shown to be a feasible combination for patients previously treated with an anthracycline and a taxane. Each drug in combination can be administered at efficacious doses.
This population has few therapeutic options with established clinical benefit. The development of a new regimen and potential new standard of care for this group is important.
* Primary objective:
• to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival.
* Secondary objectives:
* to evaluate the response rate, the time to response and the duration of response in both arms
* to compare the disease control rate between arms
* to evaluate the duration of disease control in both arms
* to evaluate the overall survival in both arms
* to evaluate safety
Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of 334 patients with advanced breast cancer who have previously been treated with an anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus capecitabine (Arm A) or capecitabine alone (Arm B).
Detailed Description:
RECIST 1.1 will be used for tumor assessment CTC - CAE version 3.0 will be used for safety assessment
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?: