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

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

A phase 3 trial of Patritumab deruxtecan, Capecitabine, Doxorubicin and Trastuzumab deruxtecan in advanced solid tumours, run by Merck Sharp & Dohme LLC, now recruiting.

Recruiting

Also called: HERTHENA-Breast04

Overview Taking part Connected8

Overview

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) is a phase 3 interventional study registered as NCT07060807 by Merck Sharp & Dohme LLC, with 1000 participants planned, started 2025-07-21 and due to reach its primary completion in 2033-07-14. Interventions recorded: Patritumab deruxtecan, Paclitaxel, Nab-paclitaxel, Capecitabine, Liposomal doxorubicin and Trastuzumab deruxtecan.

Setting

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).

Phase

Phase 3

Sponsor

Merck Sharp & Dohme LLC

Registry

Started

2025-07-21

Enrolled

1,000 enrolled

Taking part

NCT07060807recruiting

Run by: Merck Sharp & Dohme LLC with 1 collaborator
Open to: 18 Years and over, any sex
Enrolment: 1,000 (estimated)
Sites: 200, 198 recruiting
Countries: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Registry updated: 2026-10-06

The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.

ClinicalTrials.gov data courtesy of the US National Library of Medicine.

Connected

8

Similar pages

Trial
Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
Shares Patritumab deruxtecan, Daiichi Sankyo, Merck & Co. (MSD), Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Shares Patritumab deruxtecan, Daiichi Sankyo, Merck & Co. (MSD), Metastatic cancer (cancer that has spread) and the tag pipeline.
Trial
Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Shares Daiichi Sankyo, Merck & Co. (MSD), Metastatic cancer (cancer that has spread), Antibody-drug conjugate (ADC) and the tag pipeline.
Trial
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Shares Daiichi Sankyo, Merck & Co. (MSD), Metastatic cancer (cancer that has spread), Antibody-drug conjugate (ADC) and the tag pipeline.
Trial
A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
Shares Daiichi Sankyo, Merck & Co. (MSD), Metastatic cancer (cancer that has spread), Antibody-drug conjugate (ADC) and the tag pipeline.
Trial
A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
Shares Daiichi Sankyo, Merck & Co. (MSD), Metastatic cancer (cancer that has spread), Antibody-drug conjugate (ADC) and the tag pipeline.
Trial
A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
Shares Daiichi Sankyo, Merck & Co. (MSD), Metastatic cancer (cancer that has spread), Antibody-drug conjugate (ADC) and the tag pipeline.
Trial
A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
Shares Patritumab deruxtecan, Daiichi Sankyo, Merck & Co. (MSD), Metastatic cancer (cancer that has spread) and the tag pipeline.

cancers

Metastatic cancer (cancer that has spread)

technologies

Antibody-drug conjugate (ADC)

drugs

ApprovedOral fluoropyrimidine prodrug (antimetabolite)

Capecitabine · Xeloda

ApprovedCytotoxic chemotherapy (anthracycline)

Doxorubicin · Adriamycin

Phase 3ADC

Patritumab deruxtecan

ApprovedADC

Trastuzumab deruxtecan · Enhertu

companies

Daiichi Sankyo Merck & Co. (MSD)

Evidence strength50/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
1,000 enrolled+15
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

Make correction

Report a readout

Cancers

Metastatic cancer (cancer that has spread)

Technologies

Antibody-drug conjugate (ADC)

Products

Patritumab deruxtecan
Capecitabine
Doxorubicin
Trastuzumab deruxtecan

Companies

Merck & Co. (MSD)
Daiichi Sankyo

Sources

Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.

ClinicalTrials.gov · 1

ClinicalTrials.gov NCT07060807

A source that has moved or gone is reported by the weekly link check. /audit/

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sourced, not expert-reviewed

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