NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer

The trial will have two cohorts. COHORT I - SoC DE-ESCALATION Cohort I will include patients with clinical stage II TNBC who have achieved a cCR to 12 weeks of NACT with CARBO/ PAC, and PEM. The trial will evaluate whether these patients can be safely spared from further chemotherapy (CTx) and directly proceed to surgery. If it is unclear whether patients have a cCR, a tumour biopsy (by ultrasound or mammography/MRI-guided) is required to confirm that there is no evidence of residual invasive disease. After surgery, patients with a pCR (ypT0/is, ypN0) will not receive further chemotherapy, but continue otherwise on SoC treatment. Patients with residual disease should be considered for postoperative SoC treatment, which might include further CTx (e.g., AC or AC x4) plus PEM or OLA (in patients with gBRCA mutations). COHORT II - ADC-INTENSIFICATION (STUDY TREATMENT) vs. SoC Cohort II will include all clinical stage III-patients and stage II patients without a cCR after 12 weeks of NACT with CARBO/ PAC and PEM. If it is unclear whether patients have a cCR, a tumour biopsy (by ultrasound or mammography/MRI-guided) is required to confirm that there is no evidence of residual invasive disease. These patients will be randomized 1:1 to further neoadjuvant treatment in either * Arm 1: neoadjuvant SG+PEM, followed by surgery and pCR-dependent post-neoadjuvant SoC treatment or * Arm 2: SoC CTx+SoC, followed by surgery and pCR-dependent post-neoadjuvant SoC treatment