An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

Condition studied

Hormone receptor positive breast cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Progression Free Survival (PFS), Overall Survival (OS)

Endpoint detail

Objective Response Rate (ORR), Duration of Response (DOR), Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score, Change from Baseline in EORTC QLQ-C30 Physical Functioning Score, Change from Baseline in EORTC QLQ-C30 Emotional Functioning Score, Change from Baseline in EORTC QLQ-C30 Pain Score, Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status-Quality of Life Score, TTD in EORTC QLQ-C30 Physical Functioning Score, TTD in EORTC QLQ-C30 Emotional Functioning Score, TTD in EORTC QLQ-C30 Pain Score, Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE