Hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) recurrent or metastatic breast cancer (MBC)
Conditions
Brief summary
Adverse events (AEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0), Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression free survival (PFS), and overall survival (OS)
Detailed description
ORR, DOR, DCR, PFS, and OS within biomarker-defined subgroups from retrospectively evaluated patient samples, Plasma alisertib concentrations collected on C1D1, C1D3, C1D8, and C1D18.
Interventions
DRUGFulvestrant STADA 250 mg injekcinis tirpalas užpildytame švirkšte
DRUGAlisertib Enteric-Coated Tablets
DRUGExemestane SanoSwiss 25 mg plėvele dengtos tabletės
DRUGAnastrozole Accord 1 mg plėvele dengtos tabletės
Sponsors
Puma Biotechnology Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0), Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression free survival (PFS), and overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, DOR, DCR, PFS, and OS within biomarker-defined subgroups from retrospectively evaluated patient samples, Plasma alisertib concentrations collected on C1D1, C1D3, C1D8, and C1D18. | — |
Countries
Portugal, Spain
Outcome results
None listed