A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Condition(s) studied
Investigational drug(s) / intervention(s)
Patritumab deruxtecan: Administered via intravenous (IV) infusion
Paclitaxel: Administered via IV infusion
Nab-paclitaxel: Administered via IV infusion
Capecitabine: Administered via oral tablets
Pegylated liposomal doxorubicin: Administered via IV infusion
Trastuzumab deruxtecan: Administered via IV infusion
Rescue Medication: Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications include: 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroids.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — Up to approximately 45 months
PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by blinded independent central review (BICR). Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. - Overall Survival (OS) — Up to approximately 85 months
OS is the length of time from when the participant starts treatment until death from any cause.
Trial sites (201)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern Cancer Center (SCC) ( Site 8000) | Daphne | Alabama | Recruiting |
| The University of Arizona Cancer Center - North Campus ( Site 0055) | Tucson | Arizona | Recruiting |
| Los Angeles Hematology Oncology Medical Group ( Site 0026) | Los Angeles | California | Recruiting |
| Hoag Memorial Hospital Presbyterian ( Site 0025) | Newport Beach | California | Recruiting |
| St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021) | Grand Junction | Colorado | Recruiting |
| Medical Oncology Hematology Consultants (MOHC) ( Site 8002) | Newark | Delaware | Recruiting |
| AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024) | Altamonte Springs | Florida | Recruiting |
| Comprehensive Hematology Oncology ( Site 0060) | St. Petersburg | Florida | Recruiting |
| Baptist Health Lexington ( Site 0050) | Lexington | Kentucky | Recruiting |
| Baptist Health Hamburg ( Site 0071) | Lexington | Kentucky | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001) | Hackensack | New Jersey | Recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 0033) | New Brunswick | New Jersey | Recruiting |
| Presbyterian Kaseman Hospital ( Site 0072) | Albuquerque | New Mexico | Recruiting |
| University of New Mexico Comprehensive Cancer Center ( Site 0047) | Albuquerque | New Mexico | Recruiting |
| Presbyterian Rust Jorgensen Cancer ( Site 0073) | Rio Rancho | New Mexico | Recruiting |
| Queens Hospital Cancer Center ( Site 0011) | Jamaica | New York | Recruiting |
| Optum Medical Care, PC ( Site 0009) | Westbury | New York | Recruiting |
| Novant Health Cancer Institute ( Site 0019) | Charlotte | North Carolina | Recruiting |
| Novant Health Oncology Specialists ( Site 0074) | Winston-Salem | North Carolina | Recruiting |
| TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020) | Cincinnati | Ohio | Recruiting |
| University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058) | Pittsburgh | Pennsylvania | Recruiting |
| Cancer Care Associates Of York ( Site 0063) | York | Pennsylvania | Recruiting |
| SCRI Oncology Partners ( Site 7000) | Nashville | Tennessee | Recruiting |
| Tennessee Oncology ( Site 0068) | Nashville | Tennessee | Recruiting |
| Texas Oncology - DFW ( Site 8003) | Dallas | Texas | Recruiting |
| JPS Health Network ( Site 0067) | Fort Worth | Texas | Recruiting |
| Texas Oncology - Gulf Coast ( Site 8006) | Houston | Texas | Recruiting |
| Oncology Consultants P.A. ( Site 0061) | Houston | Texas | Recruiting |
| Texas Oncology - Central/South Texas ( Site 8005) | McAllen | Texas | Recruiting |
| Mays Cancer Center ( Site 0049) | San Antonio | Texas | Recruiting |
| Virginia Oncology Associates (VOA) ( Site 8001) | Norfolk | Virginia | Recruiting |
| Shenandoah Oncology ( Site 8004) | Winchester | Virginia | Recruiting |
| Northwest Medical Specialties, PLLC ( Site 0062) | Tacoma | Washington | Recruiting |
| Circuit Clinical/SSM Health Dean Medical Group ( Site 0039) | Madison | Wisconsin | Recruiting |
| Hospital Aleman ( Site 0200) | Ciudad Autonoma de Buenos Aires | Buenos Aires | Recruiting |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205) | Mar del Plata | Buenos Aires | Recruiting |
| Fundación Respirar ( Site 0201) | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Centro Privado de RMI Rio Cuarto ( Site 0207) | Río Cuarto | Córdoba Province | Recruiting |
| Instituto de Oncología de Rosario ( Site 0208) | Rosario | Santa Fe Province | Recruiting |
| Instituto Alexander Fleming ( Site 0202) | CABA | Argentina | Recruiting |
+ 161 more sites — see the full list on the official registry below.
On this site
📄 Enhertu (trastuzumab deruxtecan) drug profile →More Merck Sharp & Dohme LLC trials in Italy
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 NCT07060807 on ClinicalTrials.gov ↗ ← All trials in Italy