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)
NCT ID: NCT06797635
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
372 participants
INTERVENTIONAL
2025-03-20
2034-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
NCT07060807
SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study
NCT07307287
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
NCT06747338
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
NCT06976944
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT06172478
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin
In Part 1, participants receive neoadjuvant pembrolizumab 200 mg via intravenous (IV) infusion every 3 weeks (Q3W) plus patritumab deruxtecan via IV infusion Q3W for 12 weeks, followed by pembrolizumab 200 mg via IV infusion Q3W plus paclitaxel 80 mg/m\^2 via IV infusion every week (QW) and carboplatin AUC1.5 mg/ml/min via IV infusion QW for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer.
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
Part 2, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin
In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion every Q3W plus patritumab deruxtecan (dose to be determined in part 1) IV infusion Q3W for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m\^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min IV infusion QW for 12 weeks. At 3-6 weeks after last dose of neoadjuvant treatment, participants undergo surgery for breast cancer. After surgery, participants receive adjuvant pembrolizumab 400 mg IV every 6 weeks (Q6W) for \~30 weeks. Additional adjuvant treatment of physician's choice (TPC) may be given to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline BRCA mutation \[gBRCAm\] only), capecitabine 1000-1250 mg/m\^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV Q3W or every 2 weeks (Q2W) and cyclophosphamide 600 mg/m\^2 IV Q3W or Q2W for 4 doses.
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
Part 2, B: Pembrolizumab + paclitaxel + carboplatin → Pembrolizumab + patritumab deruxtecan
In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m\^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min IV infusion QW for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus patritumab deruxtecan (dose to be determined in part 1) via IV infusion Q3W for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will receive adjuvant pembrolizumab 400 mg IV infusion Q6W for \~30 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options include olaparib 300 mg oral BID for 1 year (participants with gBRCAm only), capecitabine 1000-1250 mg/m\^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W or Q2W and cyclophosphamide 600 mg/m\^2 IV infusion Q3W or Q2W for 4 doses.
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
Part 2, C: Pembro + paclitaxel + carboplatin→ Pembro + doxorubicin (or epirubicin) +cyclophosphamide
In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m\^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min via IV infusion QW for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W and cyclophosphamide 600 mg/m\^2 IV infusion Q3W for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will receive adjuvant pembrolizumab 400 mg IV infusion Q6W for approximately 30 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options include olaparib 300 mg oral BID for 1 year (participants with gBRCAm only) or capecitabine 1000-1250 mg/m\^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK-1022-010
Identifier Type: OTHER
Identifier Source: secondary_id
2024-514376-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1307-7867
Identifier Type: REGISTRY
Identifier Source: secondary_id
1022-010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.