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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520582-51-00

Acronym

MK-1022-016

Enrollment

211

Registered

2025-09-29

Start date

2025-10-17

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone receptor positive breast cancer

Brief summary

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

Detailed description

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

Interventions

DRUGPACLITAXEL

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGMK-1022

DRUGDOXORUBICIN

DRUGTRASTUZUMAB DERUXTECAN

DRUGCAPECITABINE

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGLIPOSOMAL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS), Overall Survival (OS)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

—

Countries

France, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026