NCT05104866: A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator’s Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

NCT05104866
Breast Cancer Type: HR+ & HER2-negative
Hormone Mutations: ER+, PR+
Other Mutations: 
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 3
Drug Category: Chemotherapy, Therapeutic antibody

Key Eligibility Criteria:

Gender: All
Age: 18 Years and older (Adult, Older Adult)
Location of Metastases: 
Additional Notes: Patients must have been treated with 1 to 2 lines of prior standard of care chemotherapy in the metastatic setting
Exclusions: Patients with bone-only metastases; Patients with known, untreated, active brain metastases; Patients with leptomeningeal disease; Patients that have previously been treated with a chemotherapeutic agent targeting topoisomerase I or TROP2 (e.g. Enhertu/trastuzumab deruxtecan, Trodelvy/sacituzumab govitecan, datopotamab deruxtecan, irinotecan, etirinotecan pegol)
https://ClinicalTrials.gov/show/NCT05104866

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