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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study summary
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:
* 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
Eligibility
Primary outcome measure(s)
- Number of Participants Experiencing Dose-Limiting Toxicity (DLT) — Up to 21 days
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The number of participants who experience a DLT will be presented. - Number of Participants with One or More Adverse Events (AEs) — Up to approximately 13 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented. - Number of Participants who Discontinue Study Intervention Due to an AE — Up to approximately 12 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus ( Site 0057) | Aurora | Colorado | Recruiting |
| Dana-Farber Cancer Institute ( Site 0050) | Boston | Massachusetts | Recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 0052) | New Brunswick | New Jersey | Recruiting |
| Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053) | Greenville | South Carolina | Recruiting |
| Inova Schar Cancer Institute ( Site 0051) | Fairfax | Virginia | Recruiting |
| Kingston General Hospital ( Site 0061) | Kingston | Ontario | Recruiting |
| Princess Margaret Cancer Centre ( Site 0001) | Toronto | Ontario | Recruiting |
| Centre Hospitalier de l'Université de Montréal ( Site 0004) | Montreal | Quebec | Recruiting |
| Jewish General Hospital ( Site 0003) | Montreal | Quebec | Recruiting |
| Rambam Health Care Campus ( Site 0011) | Haifa | Israel | Recruiting |
| Rabin Medical Center ( Site 0012) | Petah Tikva | Israel | Recruiting |
| Sheba Medical Center ( Site 0010) | Ramat Gan | Israel | Recruiting |
| Nagoya City University Hospital ( Site 0020) | Nagoya | Aichi-ken | Recruiting |
| Seoul National University Hospital ( Site 0030) | Seoul | South Korea | Recruiting |
| Asan Medical Center ( Site 0031) | Seoul | South Korea | Recruiting |
| University College London Hospital ( Site 0041) | London | Camden | Recruiting |
| The Beatson West of Scotland Cancer Centre ( Site 0043) | Glasgow | Glasgow City | Recruiting |
| St Bartholomew s Hospital ( Site 0040) | London | London, City of | Recruiting |
On this site
📄 Herceptin (trastuzumab) drug profile →More Merck Sharp & Dohme LLC trials in Israel
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06686394 on ClinicalTrials.gov ↗ ← All trials in Israel