Advanced or metastatic triple-negative breast cancer
Conditions
Brief summary
Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria)
Detailed description
Time to response (TTR), Duration of Response (DoR), Progression free survival (PFS) and Overall Survival (OS), AEs and SAEs (all grade, per NCI-CTCAE v5.0), Association between PLX038 efficacy and homologous recombination (HR) defect (assessed by HR genes mutational status and BCRAness phenotype), replication stress-related biomarkers such as SFLN11 expression, RB1 loss, PK/PD analysis, Exploratory: Association between PLX038 efficacy and tumor or blood biomarkers., Exploratory: Centrally determined ORR and PFS.
Interventions
DRUGPLX038
Sponsors
Institut Curie, Institut Curie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to response (TTR), Duration of Response (DoR), Progression free survival (PFS) and Overall Survival (OS), AEs and SAEs (all grade, per NCI-CTCAE v5.0), Association between PLX038 efficacy and homologous recombination (HR) defect (assessed by HR genes mutational status and BCRAness phenotype), replication stress-related biomarkers such as SFLN11 expression, RB1 loss, PK/PD analysis, Exploratory: Association between PLX038 efficacy and tumor or blood biomarkers., Exploratory: Centrally determined ORR and PFS. | — |
Countries
France
Outcome results
None listed