Advanced triple-negative breast cancer (TNBC), Advanced HR[+]/HER2[–] breast cancer.
Conditions
Brief summary
Co-primary endpoints: Incidence of grade ≥2 diarrhea as assessed by the Investigator, with severity determined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v.5.0) at cycle 2., Co-primary endpoints: Incidence of grade ≥3 neutropenia as assessed by the Investigator, with severity determined by NCI-CTCAE v.5.0 at cycle 2.
Detailed description
Incidence of all grades and grade ≥3 diarrhea., Incidence of all grades and grade ≥3 neutropenia, Incidence of febrile neutropenia and additional adverse events (AEs) as per NCI-CTCAE v.5.0., Discontinuation rate., Dose reduction rate, Objective response rate (ORR)., Clinical benefit rate (CBR), Duration of response (DoR)., Time to response (TtR)., Best percentage of change from baseline in the size of target tumor lesions., Progression-free survival (PFS)., Exploratory endpoints: Relationship between tumor-related biomarkers and treatment efficacy (mutational tumor load; cytokine profiling; etc.), Exploratory endpoints: Changes in mutation and copy number in oncogenes, tumor suppressors, and/or other genes associated with disease progression assessed in liquid biopsy and/or tumor tissue., Exploratory endpoints: Changes in gut microbiome and metabolomic profile in stool samples.
Interventions
DRUGAccofil 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe
DRUGNeupogen Singleject 48 MU (0.96 mg/ml) solution for injection in a pre-filled syringe filgrastim
DRUGNeupogen Singleject 30 MU (0.6 mg/ml) solution for injection in a pre-filled syringe filgrastim
DRUGLoperamide Hydrochloride 2mg Tablets
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
Sponsors
Medica Scientia Innovation Research S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoints: Incidence of grade ≥2 diarrhea as assessed by the Investigator, with severity determined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v.5.0) at cycle 2., Co-primary endpoints: Incidence of grade ≥3 neutropenia as assessed by the Investigator, with severity determined by NCI-CTCAE v.5.0 at cycle 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of all grades and grade ≥3 diarrhea., Incidence of all grades and grade ≥3 neutropenia, Incidence of febrile neutropenia and additional adverse events (AEs) as per NCI-CTCAE v.5.0., Discontinuation rate., Dose reduction rate, Objective response rate (ORR)., Clinical benefit rate (CBR), Duration of response (DoR)., Time to response (TtR)., Best percentage of change from baseline in the size of target tumor lesions., Progression-free survival (PFS)., Exploratory endpoints: Relationship between tumor-related biomarkers and treatment efficacy (mutational tumor load; cytokine profiling; etc.), Exploratory endpoints: Changes in mutation and copy number in oncogenes, tumor suppressors, and/or other genes associated with disease progression assessed in liquid biopsy and/or tumor tissue., Exploratory endpoints: Changes in gut microbiome and metabolomic profile in stool samples. | — |
Countries
Spain
Outcome results
None listed