ATM, BARD1, CHEK2, FANCC, PALB2, patients with unresectable or metastatic HER2 negative breast cancer and a deleterious germline mutation in BRCA 1/2, RAD51C, RAD51D, SLX4, XRCC2 or a homologous recombination deficiency
Conditions
Brief summary
Overall Response confirmed complete response (CR) or partial response (PR) per RECIST v1.1 criteria (time frame: baseline to 27 weeks).
Detailed description
duration of response (DOR) defined as the time between the date of first response (CR or PR) to the date of first tumor progression, progression free survival (PFS) defined as the time between the date of study entry and the first date of progression or death, overall survival (OS) defined as the time between the date of study entry and the date of death due to any cause, incidence of adverse events, serious adverse events, fatal events
Interventions
DRUGPEMBROLIZUMAB
DRUGOLAPARIB
Sponsors
Institut fuer Frauengesundheit GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response confirmed complete response (CR) or partial response (PR) per RECIST v1.1 criteria (time frame: baseline to 27 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of response (DOR) defined as the time between the date of first response (CR or PR) to the date of first tumor progression, progression free survival (PFS) defined as the time between the date of study entry and the first date of progression or death, overall survival (OS) defined as the time between the date of study entry and the date of death due to any cause, incidence of adverse events, serious adverse events, fatal events | — |
Countries
Germany
Outcome results
None listed