Locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in patients who have received an endocrine-based regimen
Conditions
Brief summary
PFS is the time from the date of randomization until the date of first objective progressive disease (PD) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause, whichever comes first
Detailed description
OS is the time from randomization until the date of death from any cause, ORR is defined as the percentage of patients who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1, Change from baseline in the physical functioning domain at Week 16, TTD of Global Health Status/QoL domain of the EORTC QLQ-C30 is defined as the time from date of randomization to the first time a patient experienced change from baseline equal or greater than the pre-specified threshold value for worsening or death, PFS is the time from the date of randomization until the date of first objective PD as assessed by the investigator per RECIST v1.1, or death from any cause, whichever comes first, ORR is defined as the percentage of patients who have achieved CR or PR that is confirmed at least 4 weeks after initial documentation of response as assessed by the investigator per RECIST v1.1, DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first) as assessed by BICR and the investigator per RECIST v1.1, The incidence of adverse events (AEs) and serious adverse events (SAEs), Percentage of patients who experience clinically significant laboratory and/or vital sign abnormalities
Interventions
DRUG-
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS is the time from the date of randomization until the date of first objective progressive disease (PD) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| OS is the time from randomization until the date of death from any cause, ORR is defined as the percentage of patients who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by BICR per RECIST v1.1, Change from baseline in the physical functioning domain at Week 16, TTD of Global Health Status/QoL domain of the EORTC QLQ-C30 is defined as the time from date of randomization to the first time a patient experienced change from baseline equal or greater than the pre-specified threshold value for worsening or death, PFS is the time from the date of randomization until the date of first objective PD as assessed by the investigator per RECIST v1.1, or death from any cause, whichever comes first, ORR is defined as the percentage of patients who have achieved CR or PR that is confirmed at least 4 weeks after initial documentation of response as assessed by the investigator per RECIST v1.1, DOR i | — |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Spain
Outcome results
None listed