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Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.
Official title: An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
372
Start Date
2025-03-20
Completion Date
2034-12-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Patritumab deruxtecan
Administered via IV infusion as neoadjuvant treatment
Pembrolizumab
Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2
Paclitaxel
Administered via IV infusion as neoadjuvant treatment
Carboplatin
Administered via IV infusion as neoadjuvant treatment
Doxorubicin hydrochloride
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Epirubicin hydrochloride
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Cyclophosphamide
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Capecitabine
Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2
Olaparib
Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2
Locations (17)
UCLA Hematology/Oncology - Parkside ( Site 0021)
Santa Monica, California, United States
Orchard Healthcare Research Inc. ( Site 0006)
Skokie, Illinois, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)
Billings, Montana, United States
Northwest Cancer Specialists (Compass Oncology) ( Site 8003)
Tigard, Oregon, United States
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States
Texas Oncology - DFW ( Site 8000)
Dallas, Texas, United States
Houston Methodist Hospital ( Site 0022)
Houston, Texas, United States
Virginia Oncology Associates (VOA) ( Site 8001)
Norfolk, Virginia, United States
Seoul National University Hospital ( Site 2400)
Seoul, South Korea
Severance Hospital, Yonsei University Health System ( Site 2402)
Seoul, South Korea
Asan Medical Center ( Site 2401)
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)
Badalona, Catalonia, Spain
Clinica Universidad de Navarra ( Site 1703)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Reina Sofia ( Site 1702)
Córdoba, Spain
Taichung Veterans General Hospital ( Site 2502)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 2503)
Tainan, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)
Taipei, Taiwan