A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

The main exclusion criteria include but are not limited to the following:

• Has breast cancer amenable to treatment with curative intent
• Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator
• Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option
• Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications
• Has any of the following: a pulse oximeter reading <92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Has ≥Grade 2 peripheral neuropathy.
• Has clinically significant corneal disease
• Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
• Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy
• Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
• Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening
• Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients
• Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients