TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.
ER + PR negative or low positive (≤10% positive cells in IHC), and HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative) breast cancer
All patients, independent from gender
≥18 years at diagnosis
Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes.
Known hypersensitivity reaction to the compounds or incorporated substances of the IMPs
Prior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
Any history of invasive breast cancer
Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor
Parallel
Sacituzumab govitecan
Drug10 mg/kg twice on Days 1 and 8 of a continuous 21-day treatment cycle
Pembrolizumab
Drug200 mg every 3 weeks (q3w)
pathological complete remission (pCR)
no invasive tumour in breast and lymph nodes (ypT0/is and ypN0)
invasive disease-free survival rate (iDFS),
time from date of first diagnosis to any invasive breast cancer event, death or secondary malignancy according to STEEP 2.0 criteria
Overall survival (OS)
time from first diagnosis to death
distant disease-free survival (dDFS)
distant disease-free survival
distant disease-free interval (dDFI)
distant disease-free interval
recurrence-free survival (RFS)
recurrence-free survival
Other pCR-definitions
ypT0/is, any ypN * ypT0, ypN0 * near pCR (ypT1a/is, any ypN)
stromal tumour infiltrating lymphocytes (sTIL)
percentage of sTIL
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