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

StatusRecruiting
PhasePhase 3
Started2025-07-21
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 52 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-29
Interventions modified
2026-08-27
Study Status, Contacts/Locations v51
Study sites199 entries, revised
Tennessee Oncology, PLLC ( Site 0068)
2026-08-20
Study Status, Contacts/Locations v50
Study sites198→199
2026-08-13
Study Status, Contacts/Locations v49
Study sites197→198
2026-08-05
Study Status, Contacts/Locations v48
Study sites195→197
Show 3 earlier versions
2026-07-28
Study Identification, Study Status v47
Re-verified, no change to tracked fields
2026-07-21
Study Status, Contacts/Locations v46
Study sites193→195
2026-07-15
Study Status, Contacts/Locations v45
Study sites192→193
2026-07-09
Study Status, Contacts/Locations v44
Trial sites expanded: 184 → 192 locations
2026-06-26
Study Status, Contacts/Locations v43
Study sites183→184
2026-06-12
Study Status, Contacts/Locations v42
Study sites182→183
2026-06-05
Study Status, Contacts/Locations v41
Study sites181→182
2026-05-29
Study Status, Contacts/Locations v40
Study sites179→181
2026-05-20
Study Status, Contacts/Locations v39
Study sites178→179
2026-05-13
Study Status, Contacts/Locations v38
Study sites176→178
2026-05-06
Study Status, Contacts/Locations v37
Study sites174→176
2026-04-30
Study Status, Contacts/Locations v36
Trial sites expanded: 171 → 174 locations
2026-04-22
Study Status, Contacts/Locations v35
Trial sites expanded: 168 → 171 locations
2026-04-14
Study Status, Contacts/Locations v34
Trial sites expanded: 163 → 168 locations
Trial sites expanded: 159 → 163 locations
2026-04-10
Study Status, Contacts/Locations v33
Study sites159→163
2026-04-01
Study Status, Contacts/Locations v32
Trial sites expanded: 154 → 159 locations
2026-03-25
Study Status, Contacts/Locations v31
Trial sites expanded: 151 → 154 locations
2026-03-19
Study Status, Contacts/Locations v30
Study sites149→151
2026-03-13
Study Status, Contacts/Locations v29
Study sites144→149
2026-03-04
Study Status, Contacts/Locations v28
Study sites137→144
2026-02-25
Study Status, Contacts/Locations v27
Study sites132→137
2026-02-17
Study Status, Contacts/Locations v26
Study sites128→132
2026-02-12
Study Status, Contacts/Locations v25
Study sites122→128
2026-02-03
Study Status, Contacts/Locations v24
Study sites115→122
2026-01-28
Study Status, Contacts/Locations v23
Study sites112→115
2026-01-21
Study Status, Contacts/Locations v22
Study sites111→112
2026-01-15
Study Status, Contacts/Locations v21
Study sites97→111
2026-01-07
Study Status, Contacts/Locations v20
Study sites92→97
2025-12-23
Study Status, Contacts/Locations v19
Study sites82→92
2025-12-17
Study Status, Contacts/Locations v18
Study sites78→82
2025-12-10
Study Status, Contacts/Locations v17
Study sites70→78
2025-12-02
Study Status, Contacts/Locations v16
Study sites65→70
2025-11-26
Study Status, Contacts/Locations v15
Study sites56→65
2025-11-20
Study Status, Contacts/Locations v14
Study sites44→56
2025-11-11
Study Status, Contacts/Locations v13
Study sites36→44
2025-11-07
Study Status, Contacts/Locations v12
Study sites26→36
2025-10-29
Study Status, Contacts/Locations v11
Study sites21→26
2025-10-24
Study Status, Contacts/Locations v10
Study sites19→21
2025-10-17
Study Status, Contacts/Locations v9
Study sites17→19
2025-10-10
Study Status, Contacts/Locations v8
Study sites16→17
2025-10-03
Study Status, Contacts/Locations v7
Study sites13→16
2025-09-25
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v6
Study sites6→13
Eligibility criteria+84 characters
[...] sults from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain ex [...] ths from the date of last dose of adjuvant CDK4/6 inhibitor MeasurableHas measurable disease per RECIST 1.1 as assessed by the local site invest [...] ants must have well controlled HIV on antiretroviral therapy (ART) AnHas ECOGan Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before [...] her life-threatening complications Has any of the following: A a pulse oximeter reading <92% at rest, OR Requiresor requires intermit [...] [...]
Collaborators+14 characters
Daiichi Sankyo
2025-08-29
Study Status, Contacts/Locations v5
Study sites4→6
2025-08-21
Study Identification, Study Status v4
Re-verified, no change to tracked fields
2025-08-14
Study Status, Contacts/Locations v3
Study sites3→4
Merck (MSD)
401 trials monitored
See 24 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.
Trial Details
NCT Number NCT07060807
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions Breast Neoplasms
Enrollment 1,000 participants
Start Date 2025-07-21
Primary Completion 2033-07-14 (estimated)
Study Completion 2033-07-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-28