triple-negative early breast cancer
Conditions
Brief summary
Primary endpoint in cohort I: • EFS after 36 months defined as time from registration to any invasive breast cancer event, death, or secondary malignancy (same definition as iDFS) according to STEEP 2.0 criteria, Primary endpoints in cohort II: • EFS after 36 months defined as time from registration to any invasive breast cancer event, death, or secondary malignancy or local progress precluding surgery in neoadjuvant treated patients • pCR defined as no invasive disease in breast and lymph nodes (ypT0/is, ypN0) in patients of both arms
Detailed description
Clinical response measured by palpation, ultrasound, mammography, or MRI, OS defined as time from first diagnosis to death, 3-year dDFS, 3-year RFS each as defined in STEEP 2.0, 3-year LRFS, Change of HRQoL between baseline, after completion of SoC neoadjuvant treatment, and on following defined timepoints: for details see protocol, For cohort II only: Comparison of toxicity of regimen by evaluation of treatment-emergent adverse event (TEAE), adverse drug reactions (ADR), serious ADR (SADR), and serious adverse events (SAE)-rates
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 |
|---|---|
| Primary endpoint in cohort I: • EFS after 36 months defined as time from registration to any invasive breast cancer event, death, or secondary malignancy (same definition as iDFS) according to STEEP 2.0 criteria, Primary endpoints in cohort II: • EFS after 36 months defined as time from registration to any invasive breast cancer event, death, or secondary malignancy or local progress precluding surgery in neoadjuvant treated patients • pCR defined as no invasive disease in breast and lymph nodes (ypT0/is, ypN0) in patients of both arms | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response measured by palpation, ultrasound, mammography, or MRI, OS defined as time from first diagnosis to death, 3-year dDFS, 3-year RFS each as defined in STEEP 2.0, 3-year LRFS, Change of HRQoL between baseline, after completion of SoC neoadjuvant treatment, and on following defined timepoints: for details see protocol, For cohort II only: Comparison of toxicity of regimen by evaluation of treatment-emergent adverse event (TEAE), adverse drug reactions (ADR), serious ADR (SADR), and serious adverse events (SAE)-rates | — |
Outcome results
None listed