Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-03-13
372
Participants Needed
17
Research Sites
510 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has locally advanced, non-metastatic breast cancer with tumor and lymph node stages cT1c N1-N2; cT2 N0-N2; cT3 N0-N2; or cT4a-d N0-N2
- Has centrally confirmed diagnosis of triple-negative or hormone receptor low positive/HER2 negative breast cancer treated as triple-negative breast cancer
- Participants positive for Hepatitis B surface antigen (HBsAg) are eligible if they have received antiviral therapy for at least 4 weeks and have undetectable viral load
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Has an ECOG performance status of 0 to 1 within 28 days prior to randomization
- Has left ventricular ejection fraction (LVEF) of 50% or higher or above lower limit of normal as assessed by echocardiogram or MUGA scan
You will not qualify if you...
- Has uncontrolled or significant cardiovascular disease before randomization
- Has clinically significant corneal disease
- Has HIV infection with a history of Kaposi sarcoma or multicentric Castleman disease
- Has received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other T-cell receptors
- Has received any prior treatment including radiation, systemic therapy, or surgery for current breast cancer
- Has received prior treatment with anti-HER3 antibody or antibody-drug conjugate containing an exatecan derivative
- Has metastatic (Stage IV) breast cancer or cN3 nodal involvement
- Has known additional malignancy progressing or requiring treatment in past 5 years
- Has active central nervous system metastases or carcinomatous meningitis
- Has history or current pneumonitis/interstitial lung disease requiring steroids or suspected ILD/pneumonitis not ruled out
- Has active infection needing systemic therapy
- Has concurrent active Hepatitis B and Hepatitis C infection
- Has severe respiratory compromise from pulmonary illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
UCLA Hematology/Oncology - Parkside ( Site 0021)
Santa Monica, California, United States, 90404
Actively Recruiting
2
Orchard Healthcare Research Inc. ( Site 0006)
Skokie, Illinois, United States, 60077
Actively Recruiting
3
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)
Billings, Montana, United States, 59102
Actively Recruiting
4
Northwest Cancer Specialists (Compass Oncology) ( Site 8003)
Tigard, Oregon, United States, 97223
Actively Recruiting
5
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
Texas Oncology - DFW ( Site 8000)
Dallas, Texas, United States, 75246
Actively Recruiting
7
Houston Methodist Hospital ( Site 0022)
Houston, Texas, United States, 77030
Actively Recruiting
8
Virginia Oncology Associates (VOA) ( Site 8001)
Norfolk, Virginia, United States, 23502
Actively Recruiting
9
Seoul National University Hospital ( Site 2400)
Seoul, South Korea, 03080
Actively Recruiting
10
Severance Hospital, Yonsei University Health System ( Site 2402)
Seoul, South Korea, 03722
Actively Recruiting
11
Asan Medical Center ( Site 2401)
Seoul, South Korea, 05505
Actively Recruiting
12
Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)
Badalona, Catalonia, Spain, 08916
Actively Recruiting
13
Clinica Universidad de Navarra ( Site 1703)
Madrid, Madrid, Comunidad de, Spain, 28027
Actively Recruiting
14
Hospital Universitario Reina Sofia ( Site 1702)
Córdoba, Spain, 14004
Actively Recruiting
15
Taichung Veterans General Hospital ( Site 2502)
Taichung, Taiwan, 407
Actively Recruiting
16
National Cheng Kung University Hospital ( Site 2503)
Tainan, Taiwan, 704
Actively Recruiting
17
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)
Taipei, Taiwan, 112
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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