A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Recruiting · NCT07060807 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
CapecitabineLiposomal doxorubicinNab-paclitaxelPaclitaxelPatritumab deruxtecanTrastuzumab deruxtecan
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- The main inclusion criteria include but are not limited to the following:
- Has a diagnosis of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent
- Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results 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 exceptions)
- Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following:
- Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or
- Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor
- Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization
Exclusion criteria
- The main exclusion criteria include but are not limited to the following:
- Has breast cancer amenable to treatment with curative intent
- Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator
- Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option
- Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications
- Has any of the following: a pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has ≥Grade 2 peripheral neuropathy.
- Has clinically significant corneal disease
- Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy
- Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
- Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening
- Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients
- Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients
Where it is running
60 locations listed across 18 US states.
- Southern Cancer Center (SCC) ( Site 8000) - Daphne, Alabama, United States
- The University of Arizona Cancer Center - North Campus ( Site 0055) - Tucson, Arizona, United States
- Los Angeles Hematology Oncology Medical Group ( Site 0026) - Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian ( Site 0025) - Newport Beach, California, United States
- St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021) - Grand Junction, Colorado, United States
- Medical Oncology Hematology Consultants (MOHC) ( Site 8002) - Newark, Delaware, United States
- AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024) - Altamonte Springs, Florida, United States
- Comprehensive Hematology Oncology ( Site 0060) - St. Petersburg, Florida, United States
- Baptist Health Lexington ( Site 0050) - Lexington, Kentucky, United States
- Baptist Health Hamburg ( Site 0071) - Lexington, Kentucky, United States
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001) - Hackensack, New Jersey, United States
- Rutgers Cancer Institute of New Jersey ( Site 0033) - New Brunswick, New Jersey, United States
- Presbyterian Kaseman Hospital ( Site 0072) - Albuquerque, New Mexico, United States
- University of New Mexico Comprehensive Cancer Center ( Site 0047) - Albuquerque, New Mexico, United States
- Presbyterian Rust Jorgensen Cancer ( Site 0073) - Rio Rancho, New Mexico, United States
- Queens Hospital Cancer Center ( Site 0011) - Jamaica, New York, United States
- Optum Medical Care, PC ( Site 0009) - Westbury, New York, United States
- Novant Health Cancer Institute ( Site 0019) - Charlotte, North Carolina, United States
- Novant Health Oncology Specialists ( Site 0074) - Winston-Salem, North Carolina, United States
- TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020) - Cincinnati, Ohio, United States
- University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058) - Pittsburgh, Pennsylvania, United States
- Cancer Care Associates Of York ( Site 0063) - York, Pennsylvania, United States
- SCRI Oncology Partners ( Site 7000) - Nashville, Tennessee, United States
- Tennessee Oncology ( Site 0068) - Nashville, Tennessee, United States
- Texas Oncology - DFW ( Site 8003) - Dallas, Texas, United States
- JPS Health Network ( Site 0067) - Fort Worth, Texas, United States
- Texas Oncology - Gulf Coast ( Site 8006) - Houston, Texas, United States
- Oncology Consultants P.A. ( Site 0061) - Houston, Texas, United States
- Texas Oncology - Central/South Texas ( Site 8005) - McAllen, Texas, United States
- Mays Cancer Center ( Site 0049) - San Antonio, Texas, United States
- Virginia Oncology Associates (VOA) ( Site 8001) - Norfolk, Virginia, United States
- Shenandoah Oncology ( Site 8004) - Winchester, Virginia, United States
- Northwest Medical Specialties, PLLC ( Site 0062) - Tacoma, Washington, United States
- Circuit Clinical/SSM Health Dean Medical Group ( Site 0039) - Madison, Wisconsin, United States
- Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2107) - Adana, Turkey (Türkiye)
- Adana Medical Park Seyhan Hastanesi ( Site 2110) - Adana, Turkey (Türkiye)
- Akita University Hospital ( Site 3207) - Akita, Japan
- Hacettepe Universite Hastaneleri ( Site 2100) - Ankara, Turkey (Türkiye)
- Memorial Ankara Hastanesi ( Site 2106) - Ankara, Turkey (Türkiye)
- Gazi University Health Research and Application Center Gazi Hospital ( Site 2101) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi ( Site 2105) - Ankara, Turkey (Türkiye)
- Hospital Clinic de Barcelona ( Site 1821) - Barcelona, Spain
- Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 1202) - Budapest, Hungary
- Országos Onkológiai Intézet-B-Belgyógyászati Onkológiai Osztály ( Site 1201) - Budapest, Hungary
- Instituto Alexander Fleming ( Site 0202) - CABA, Argentina
- Chiba Cancer Center ( Site 3203) - Chiba, Japan
- Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 0602) - Chihuahua City, Mexico
- Hospital Italiano de Córdoba ( Site 0206) - Córdoba, Argentina
- Dicle Üniversitesi ( Site 2102) - Diyarbakır, Turkey (Türkiye)
- National Hospital Organization Kyushu Cancer Center ( Site 3208) - Fukuoka, Japan
- Fukushima Medical University Hospital ( Site 3212) - Fukushima, Japan
- Rambam Health Care Campus ( Site 1401) - Haifa, Israel
- Hiroshima City Hiroshima Citizens Hospital ( Site 3214) - Hiroshima, Japan
- Prince of Wales Hospital ( Site 3301) - Hong Kong, Hong Kong
- Princess Margaret Hospital. ( Site 3302) - Hong Kong, Hong Kong
- Tuen Mun Hospital ( Site 3303) - Hong Kong, Hong Kong
- Koç Üniversitesi Hastanesi ( Site 2104) - Istanbul, Turkey (Türkiye)
- Shaare Zedek Medical Center ( Site 1406) - Jerusalem, Israel
- Hadassah Medical Center ( Site 1404) - Jerusalem, Israel
- Social medical corporation Hakuaikai Sagara Hospital ( Site 3219) - Kagoshima, Japan
Showing 60 of 199 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →