Malignant Neoplasm of Breast Clinical Trial
Official title:
A Multicenter, Randomised, Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously
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).
RECIST 1.1 will be used for tumor assessment CTC - CAE version 3.0 will be used for safety assessment ;
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