Patients with high risk of relapse, ER+ and HER2- primary non-metastatic breast cancer who remain disease-free
Conditions
Brief summary
Disease free survival rate (DFS) after randomisation (disease is defined as local, regional or metastatic relapse, a new contralateral breast cancer, or death from any cause).
Detailed description
Efficacy : Overall survival rate (OS) for the whole population, Efficacy : DFS and OS for ER+ and PR+ subgroup, Efficacy : DFS and OS for the ER+/PR – subgroup, Efficacy : EFS, Efficacy : DMFS, Efficacy : BMFS, Efficacy : Secondary cancer, Toxicity : CTC-AE scale version 4.0., Biological : Predictive value of mTOR activation markers on DFS: IHC analysis of primary tumor for pS6K and p4EBP, Biological : Other translational analyses linking cancer biology with outcomes, Other : Quality of life: QLQ C30, Other : EFS and DMFS in low risk patients (according to the EPClin score), Other : Sociologic study
Interventions
DRUGPLACEBO
Sponsors
Unicancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival rate (DFS) after randomisation (disease is defined as local, regional or metastatic relapse, a new contralateral breast cancer, or death from any cause). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy : Overall survival rate (OS) for the whole population, Efficacy : DFS and OS for ER+ and PR+ subgroup, Efficacy : DFS and OS for the ER+/PR – subgroup, Efficacy : EFS, Efficacy : DMFS, Efficacy : BMFS, Efficacy : Secondary cancer, Toxicity : CTC-AE scale version 4.0., Biological : Predictive value of mTOR activation markers on DFS: IHC analysis of primary tumor for pS6K and p4EBP, Biological : Other translational analyses linking cancer biology with outcomes, Other : Quality of life: QLQ C30, Other : EFS and DMFS in low risk patients (according to the EPClin score), Other : Sociologic study | — |
Countries
Belgium, France
Outcome results
None listed