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)
Recruiting now · Phase 2
Conditions studied: Breast Neoplasms, Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06797635
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 372
- Starts
- 2025-03-20
- Expected to finish
- 2034-12-31
- Last updated by the study team
- 2026-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The main inclusion criteria include but are not limited to the following:
- Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2
- Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization
- Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan
You may not qualify if…
- The main exclusion criteria include but are not limited to the following:
- Has uncontrolled or significant cardiovascular disease before randomization
- Has any history of or evidence of any current leptomeningeal carcinomatosis.
- Has clinically significant corneal disease
- Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease
- Has evidence of ongoing, uncontrolled, systemic bacterial, fungal, or viral infection
- Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
- Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)
- Has metastatic (Stage IV) breast cancer or cN3 nodal involvement
- Has known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current or suspected ILD
- Has an active infection requiring systemic therapy
- Has concurrent active HBV and HCV infection
- Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
Where it is running
- UCLA Hematology/Oncology - Parkside ( Site 0021) — Santa Monica, California, United States (enrolling)
- Orchard Healthcare Research Inc. ( Site 0006) — Skokie, Illinois, United States (enrolling)
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003) — Billings, Montana, United States (enrolling)
- Northwest Cancer Specialists (Compass Oncology) ( Site 8003) — Tigard, Oregon, United States (enrolling)
- SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee, United States (enrolling)
- Texas Oncology - DFW ( Site 8000) — Dallas, Texas, United States (enrolling)
- Houston Methodist Hospital ( Site 0022) — Houston, Texas, United States (enrolling)
- Virginia Oncology Associates (VOA) ( Site 8001) — Norfolk, Virginia, United States (enrolling)
- Seoul National University Hospital ( Site 2400) — Seoul, South Korea (enrolling)
- Severance Hospital, Yonsei University Health System ( Site 2402) — Seoul, South Korea (enrolling)
- Asan Medical Center ( Site 2401) — Seoul, South Korea (enrolling)
- Institut Català d'Oncologia (ICO) - Badalona ( Site 1700) — Badalona, Catalonia, Spain (enrolling)
- Clinica Universidad de Navarra ( Site 1703) — Madrid, Madrid, Comunidad de, Spain (enrolling)
- Hospital Universitario Reina Sofia ( Site 1702) — Córdoba, Spain (enrolling)
- Taichung Veterans General Hospital ( Site 2502) — Taichung, Taiwan (enrolling)
- National Cheng Kung University Hospital ( Site 2503) — Tainan, Taiwan (enrolling)
- Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501) — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.