PIK3CA mutated HER2+ advanced or relapsed breast cancer (BC) previously treated with trastuzumab
Conditions
Brief summary
PFS: Time from randomization to objective disease progression based on the investigator's assessment according to the response evaluation criteria for solid tumors (RECIST) version 1.1., or death from any cause.
Detailed description
OS: time from randomization to death from any cause., OR: complete or partial response as best overall response based on the investigator’s assessment according to RECIST version 1.1., Safety and tolerability: adverse events (AEs) grades will be defined by the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. AE terms will be coded according to the MedDRA dictionary.
Interventions
DRUGALPELISIB
Sponsors
Fundacion Grupo Espanol De Investigacion En Cancer De Mama
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS: Time from randomization to objective disease progression based on the investigator's assessment according to the response evaluation criteria for solid tumors (RECIST) version 1.1., or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS: time from randomization to death from any cause., OR: complete or partial response as best overall response based on the investigator’s assessment according to RECIST version 1.1., Safety and tolerability: adverse events (AEs) grades will be defined by the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. AE terms will be coded according to the MedDRA dictionary. | — |
Countries
Spain
Outcome results
None listed