Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Required: TACSTD2 any tested (testing required; no eligibility threshold specified)

Excluded: BRCA1 deleterious or suspected deleterious mutation

Excluded: BRCA2 deleterious or suspected deleterious mutation

Must have received: neoadjuvant chemotherapy and immunotherapy (pembrolizumab, carboplatin, taxane, anthracycline) — neoadjuvant

Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery

Must have received: adjuvant radiation therapy — adjuvant

Completed adjuvant radiation therapy (if indicated) and recovered before randomization

Cannot have received: TROP2-directed antibody-drug conjugate

Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC)

Cannot have received: topoisomerase I inhibitor-containing antibody-drug conjugate

Received prior treatment with a ... topoisomerase I inhibitor-containing ADC

Cannot have received: systemic anticancer therapy (adjuvant phase)

Exception: adjuvant radiation therapy allowed

Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy

Cannot have received: anti-PD-1 therapy

Exception: pembrolizumab as neoadjuvant therapy for early-stage TNBC allowed

Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster of differentiation (CD) 134], or CD137)

Cannot have received: systemic anticancer therapy

Exception: chemotherapy as neoadjuvant therapy for early-stage TNBC allowed

Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization

Cannot have received: radiation therapy

Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention