Triple-negative early breast cancer with low risk for recurrence
Conditions
Brief summary
The two primary endpoints are: • pCR defined as no invasive tumour in breast and lymph nodes (ypT0/is, ypN0) • 3-year iDFS, defined as time from date of first diagnosis to any invasive breast cancer event, death, or secondary malignancy according to STEEP 2.0 criteria
Detailed description
Clinical response measured by palpation, ultrasound, and mammography, Overall survival defined as time from date of first diagnosis to death, 3-year dDFS, 3-year dDFI, 3-year RFS, 3-year LRFS, 3-year BCFI, Change of health-related quality of life between baseline and after defined timepoints: after 2, 4, and 6 cycles (if applicable), before surgery, every 6 months in follow-up until year 3 and yearly afterwards.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
Sponsors
WSG Westdeutsche Studiengruppe GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The two primary endpoints are: • pCR defined as no invasive tumour in breast and lymph nodes (ypT0/is, ypN0) • 3-year iDFS, defined as time from date of first diagnosis to any invasive breast cancer event, death, or secondary malignancy according to STEEP 2.0 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response measured by palpation, ultrasound, and mammography, Overall survival defined as time from date of first diagnosis to death, 3-year dDFS, 3-year dDFI, 3-year RFS, 3-year LRFS, 3-year BCFI, Change of health-related quality of life between baseline and after defined timepoints: after 2, 4, and 6 cycles (if applicable), before surgery, every 6 months in follow-up until year 3 and yearly afterwards. | — |
Countries
Germany
Outcome results
None listed