Breast cancer
Conditions
Brief summary
To determine Progression-free survival (PFS), defined as time from study enrollment to disease progression or death from any cause, with censoring when fulvestrant and alpelisib are stopped and another treatment is initiated without confirmed disease progression.
Detailed description
To determine Progression-free survival (PFS) 'on treatment' defined as time from study enrollment to disease progression or death from any cause, with censoring when fulvestrant and alpelisib are stopped earlier than disease progression, to determine the Objective Response Rate (CR/PR), to determine the Clinical Benefit Rate (SD/CR/PR), to determine the Duration of Response (DoR), to evaluate safety and tolerability, to determine risk factors for alpelisib-induced hyperglycemia, to determine which management is needed in patients with alpelisib-induced hyperglycemia, and time till resolvement, to assess Quality of Life (QoL), to evaluate Patient Reported Outcome Measures (PROMs), to compare PFS in patients with the 11 most frequent activating PIK3CA mutations with PFS in patients with unselected activating PIK3CA mutations (including rare mutations), to determine Overall Survival (OS), to determine pharmacokinetics of alpelisib
Interventions
Sponsors
BOOG Study Center B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine Progression-free survival (PFS), defined as time from study enrollment to disease progression or death from any cause, with censoring when fulvestrant and alpelisib are stopped and another treatment is initiated without confirmed disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine Progression-free survival (PFS) 'on treatment' defined as time from study enrollment to disease progression or death from any cause, with censoring when fulvestrant and alpelisib are stopped earlier than disease progression, to determine the Objective Response Rate (CR/PR), to determine the Clinical Benefit Rate (SD/CR/PR), to determine the Duration of Response (DoR), to evaluate safety and tolerability, to determine risk factors for alpelisib-induced hyperglycemia, to determine which management is needed in patients with alpelisib-induced hyperglycemia, and time till resolvement, to assess Quality of Life (QoL), to evaluate Patient Reported Outcome Measures (PROMs), to compare PFS in patients with the 11 most frequent activating PIK3CA mutations with PFS in patients with unselected activating PIK3CA mutations (including rare mutations), to determine Overall Survival (OS), to determine pharmacokinetics of alpelisib | — |
Countries
Netherlands
Outcome results
None listed