Breast cancer
Conditions
Brief summary
Progression-free survival after two lines of treatment (PFS2) defined as time from randomization until one of the following (whichever occurs first): second objective disease progression or objective disease progression on second-line therapy, whichever occurs first, symptomatic deterioration on second-line therapy leading to discontinuation of second-line therapy initiation of chemotherapy for breast cancer or death
Detailed description
Overall survival, Quality of life, Safety and tolerability, Objective response rate (ORR), Cost-effectiveness, Type and incidence of grade 3 and 4 (serious) adverse events ((S)AE) (as graded by NCI CTCAE v4.0) and its relation to study medications., Tumor tissue biomarkers, including genes, proteins and (mi)RNA expression, Circulating tumor DNA (ctDNA) in plasma, Nuclear imaging, including FDG-PET and FES-PET, Pharmacokinetics, -dynamics and -genomics of CDK4/6 inhibitors, Cognitive functioning as assessed by validated online cognitive tests
Interventions
DRUGVerzenios 50 mg film-coated tablets
DRUGGOSERELIN
DRUGESTRADIOL
DRUGANASTROZOLE
DRUGFULVESTRANT
DRUGLEUPRORELIN
DRUGLETROZOLE
Sponsors
BOOG Study Center B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival after two lines of treatment (PFS2) defined as time from randomization until one of the following (whichever occurs first): second objective disease progression or objective disease progression on second-line therapy, whichever occurs first, symptomatic deterioration on second-line therapy leading to discontinuation of second-line therapy initiation of chemotherapy for breast cancer or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Quality of life, Safety and tolerability, Objective response rate (ORR), Cost-effectiveness, Type and incidence of grade 3 and 4 (serious) adverse events ((S)AE) (as graded by NCI CTCAE v4.0) and its relation to study medications., Tumor tissue biomarkers, including genes, proteins and (mi)RNA expression, Circulating tumor DNA (ctDNA) in plasma, Nuclear imaging, including FDG-PET and FES-PET, Pharmacokinetics, -dynamics and -genomics of CDK4/6 inhibitors, Cognitive functioning as assessed by validated online cognitive tests | — |
Countries
Netherlands
Outcome results
None listed