TrialPath
← Back to searchRecruiting

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)

NCT06797635 · Merck Sharp & Dohme LLC
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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)
About this study
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.
Eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has uncontrolled or significant cardiovascular disease before randomization * Has clinically significant corneal disease * Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease * 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 a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ILD/pneumonitis cannot be ruled out by standard diagnostic assessments * Has an active infection requiring systemic therapy * Has concurrent active HBV and HCV infection * Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
Study design
Enrollment target: 372 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-20
Estimated completion: 2034-12-31
Last updated: 2026-03-13
Interventions
Biological: Patritumab deruxtecanBiological: PembrolizumabDrug: PaclitaxelDrug: CarboplatinDrug: Doxorubicin hydrochlorideDrug: Epirubicin hydrochlorideDrug: CyclophosphamideDrug: CapecitabineDrug: Olaparib
Primary outcomes
  • Part 1: Number of Participants Experiencing an Adverse Event (AE) (Up to ~43 weeks)
  • Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) (Up to 21 days)
  • Part 1: Number of Participants who Discontinued Study Treatment Due to an AE (Up to ~30 weeks)
Sponsor
Merck Sharp & Dohme LLC · industry
With: Daiichi Sankyo
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (17)
UCLA Hematology/Oncology - Parkside ( Site 0021)Recruiting
Santa Monica, California, United States
Orchard Healthcare Research Inc. ( Site 0006)Recruiting
Skokie, Illinois, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)Recruiting
Billings, Montana, United States
Northwest Cancer Specialists (Compass Oncology) ( Site 8003)Recruiting
Tigard, Oregon, United States
SCRI Oncology Partners ( Site 7000)Recruiting
Nashville, Tennessee, United States
Texas Oncology - DFW ( Site 8000)Recruiting
Dallas, Texas, United States
Houston Methodist Hospital ( Site 0022)Recruiting
Houston, Texas, United States
Virginia Oncology Associates (VOA) ( Site 8001)Recruiting
Norfolk, Virginia, United States
Seoul National University Hospital ( Site 2400)Recruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health System ( Site 2402)Recruiting
Seoul, South Korea
Asan Medical Center ( Site 2401)Recruiting
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)Recruiting
Badalona, Catalonia, Spain
Clinica Universidad de Navarra ( Site 1703)Recruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Reina Sofia ( Site 1702)Recruiting
Córdoba, Spain
Taichung Veterans General Hospital ( Site 2502)Recruiting
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 2503)Recruiting
Tainan, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)Recruiting
Taipei, Taiwan