Comparing Patritumab deruxtecan with Paclitaxel for breast neoplasms

Exclusion

• −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
• −The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• −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 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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →; 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 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 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
• −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