Metastatic breast cancer, including triple negative breast cancer (TNBC), hormone receptor positive breast cancer (HR+ BC), and HER2 positive and HER2 low breast cancer (HER2+/HER2-low BC)
Conditions
Brief summary
Stage 1 1. ORR, Stage 1 and 2 1. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0, Stage 1 and 2 2. Change from baseline in vital signs and electrocardiogram parameters, Stage 1 and 2 3. Change from baseline in targeted clinical laboratory test results
Detailed description
Stage 1 1. PFS, Stage 1 2. DCR, Stage 1 3. OS, Stage 1 4. DOR, Stage 1 5. OS at specific timepoints
Interventions
DRUGINAVOLISIB
DRUGVerzenios 50 mg film-coated tablets
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGTecentriq
DRUGACTEMRA
DRUGSACITUZUMAB GOVITECAN
DRUG5 mg
DRUGcomprimé pelliculé
DRUGFULVESTRANT ACCORD 250 mg
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGRoActemra 20 mg/mL concentrate for solution for infusion
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1 1. ORR, Stage 1 and 2 1. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0, Stage 1 and 2 2. Change from baseline in vital signs and electrocardiogram parameters, Stage 1 and 2 3. Change from baseline in targeted clinical laboratory test results | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage 1 1. PFS, Stage 1 2. DCR, Stage 1 3. OS, Stage 1 4. DOR, Stage 1 5. OS at specific timepoints | — |
Countries
France, Germany, Spain
Outcome results
None listed