Early invasive triple negative breast cancer with positive HRD status (acc. to Myriad mychoice© test)
Conditions
Brief summary
Main study: Histo-pathological response to pre-operative carboplatin/olaparib compared with pre-operative TAC-based chemotherapy when measured by centrally assessed RCB (RCB-0/I versus RCB-II/III)., Substudy: Incidence, nature and severity of adverse events (AEs) graded according to NCI CTCAE, most current version.
Detailed description
Main study: Occurrence of pCR at the time of surgery., Main study: Quality of Life and sexual health scores and changes from baseline as measured using EORTC QLQ-C30, EORTC QLQ-BR45 and EORTC SHQ-C22.
Interventions
DRUGLynparza 100 mg film-coated tablets
DRUGCYCLOPHOSPHAMIDE
DRUGLynparza 150 mg film-coated tablets
DRUGDOCETAXEL
DRUGDOXORUBICIN
DRUGCARBOPLATIN
DRUGEPIRUBICIN
Sponsors
Verein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Group
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study: Histo-pathological response to pre-operative carboplatin/olaparib compared with pre-operative TAC-based chemotherapy when measured by centrally assessed RCB (RCB-0/I versus RCB-II/III)., Substudy: Incidence, nature and severity of adverse events (AEs) graded according to NCI CTCAE, most current version. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main study: Occurrence of pCR at the time of surgery., Main study: Quality of Life and sexual health scores and changes from baseline as measured using EORTC QLQ-C30, EORTC QLQ-BR45 and EORTC SHQ-C22. | — |
Countries
Austria
Outcome results
None listed