Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
NCT ID: NCT06686394
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
81 participants
INTERVENTIONAL
2025-02-26
2030-04-18
Brief Summary
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* About the safety and how well people tolerate of patritumab deruxtecan
* How many people have the cancer respond (get smaller or go away) to treatment
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Patritumab deruxtecan plus trastuzumab
Participants receive patritumab deruxtecan intravenous (IV) infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
Patritumab deruxtecan
Patritumab deruxtecan administered via IV infusion
Trastuzumab
Trastuzumab administered via IV infusion
Trastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion
Patritumab deruxtecan plus pertuzumab and trastuzumab
Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
Patritumab deruxtecan
Patritumab deruxtecan administered via IV infusion
Trastuzumab
Trastuzumab administered via IV infusion
Trastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion
Pertuzumab
Pertuzumab administered via IV infusion
Patritumab deruxtecan plus trastuzumab and tucatinib
Participants receive patritumab deruxtecan IV infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks), and tucatinib is administered orally twice daily for each 21-day cycle, until disease progression, intolerable toxicity, or investigator decision.
Patritumab deruxtecan
Patritumab deruxtecan administered via IV infusion
Trastuzumab
Trastuzumab administered via IV infusion
Trastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion
Tucatinib
Tucatinib administered as oral tablets
Interventions
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Patritumab deruxtecan
Patritumab deruxtecan administered via IV infusion
Trastuzumab
Trastuzumab administered via IV infusion
Trastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion
Pertuzumab
Pertuzumab administered via IV infusion
Tucatinib
Tucatinib administered as oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention
Arm 1:
* Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
* Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment
Arm 2:
-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
Arm 3:
-Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.
Exclusion Criteria
* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
* Has clinically severe respiratory compromise
* Has any history of or evidence of any current leptomeningeal disease
* Has clinically significant corneal disease
* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
* HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Evidence of spinal cord compression or brain metastases
* Has an active infection requiring systemic therapy
* Concurrent active HBV and HCV infection
* Has had major surgical procedure (excluding placement of vascular access) less than 28 days
Arm 3 ONLY
\- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Dana-Farber Cancer Institute ( Site 0050)
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey, United States
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)
Greenville, South Carolina, United States
Inova Schar Cancer Institute ( Site 0051)
Fairfax, Virginia, United States
Kingston General Hospital ( Site 0061)
Kingston, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0004)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0003)
Montreal, Quebec, Canada
Rambam Health Care Campus ( Site 0011)
Haifa, , Israel
Rabin Medical Center ( Site 0012)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0010)
Ramat Gan, , Israel
Nagoya City University Hospital ( Site 0020)
Nagoya, Aichi-ken, Japan
Seoul National University Hospital ( Site 0030)
Seoul, , South Korea
Asan Medical Center ( Site 0031)
Seoul, , South Korea
University College London Hospital ( Site 0041)
London, Camden, United Kingdom
St Bartholomew s Hospital ( Site 0040)
London, London, City of, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-1022-009
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2041250022
Identifier Type: REGISTRY
Identifier Source: secondary_id
1022-009
Identifier Type: -
Identifier Source: org_study_id