TROPION 4

• Participant must be ≥ 18 years, at the time of signing the ICF

• Histologically confirmed unilateral or bilateral primary invasive breast cancer

• TNBC (ER < 1%, PR < 1%, HER2-negative)

• T > 2cm if node negative; or Any T, node positive

• No evidence of distant disease

• No prior surgery, radiation, systemic therapy

• ECOG PS 0 or 1

• Adequate hematologic and end-organ function

• No known germline BRCA mutation

• Time from diagnosis to randomization < 6 weeks 

• Stage IV (metastatic) TNBC

• History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery. History of malignancy, other than metastatic TNBC except a) adequately resected non-melanoma skin cancer; b) curatively treated in situ disease, or c) other solid tumours curatively treated, with no evidence of disease for ≥ 3 years.

• Had prior treatment for TNBC

• History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening

• Clinically significant corneal disease

• Any known active liver disease

• Any known active autoimmune disease that has required systemic treatment in the past 2 years

• ≥ Grade 2 peripheral neuropathy of any etiology

• History of severe hypersensitivity reactions to either the drug substances or inactive ingredients (including but not limited to polysorbate 80) of Datopotamab Deruxtecan

• History of hypersensitivity to PD-1/PD-L1 inhibitors 

Research Nurse: Hilary Thatcher

Administrator: research.oncology@mbht.nhs.uk