What this study is
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.
What's being tested
- Patritumab deruxtecan
Intervention · BIOLOGICAL
- Pembrolizumab
Intervention · BIOLOGICAL
Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2
- Paclitaxel
Intervention · DRUG
- Carboplatin
Intervention · DRUG
- Doxorubicin hydrochloride
Intervention · DRUG
- Epirubicin hydrochloride
Intervention · DRUG
- Cyclophosphamide
Intervention · DRUG
- Capecitabine
Intervention · DRUG
Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2
- Olaparib
Intervention · DRUG
Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2
All of Patritumab deruxtecan, Paclitaxel, Carboplatin
Administered via IV infusion as neoadjuvant treatment
All of Doxorubicin hydrochloride, Epirubicin hydrochloride, 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
Study details
- 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)
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Breast Neoplasms · Breast Cancer
- Enrolling
- 372 people
- Starts
- 2025-03-20
- Est. completion
- 2031-03-16
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (17)
17 openUCLA Hematology/Oncology - Parkside ( Site 0021)
Santa Monica, California, United States
- Study Coordinator · Contact424-402-9520
RecruitingOrchard Healthcare Research Inc. ( Site 0006)
Skokie, Illinois, United States
- Study Coordinator · Contact847-568-9932
RecruitingIntermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)
Billings, Montana, United States
- Study Coordinator · Contact406-238-6685
RecruitingNorthwest Cancer Specialists (Compass Oncology) ( Site 8003)
Tigard, Oregon, United States
- Study Coordinator · Contact360-944-9889
RecruitingSCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States
- Study Coordinator · Contact844-482-4812
RecruitingTexas Oncology - DFW ( Site 8000)
Dallas, Texas, United States
- Study Coordinator · Contact214-370-1067
RecruitingHouston Methodist Hospital ( Site 0022)
Houston, Texas, United States
- Study Coordinator · Contact713-441-9948
RecruitingVirginia Oncology Associates (VOA) ( Site 8001)
Norfolk, Virginia, United States
- Study Coordinator · Contact844-482-4812
Recruiting
9 sites outside the US
Seoul National University Hospital ( Site 2400)
Seoul, South Korea
- Study Coordinator · Contact+82220720850
RecruitingSeverance Hospital, Yonsei University Health System ( Site 2402)
Seoul, South Korea
- Study Coordinator · Contact+82222288135
Recruiting- Recruiting
Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)
Badalona, Catalonia, Spain
- Study Coordinator · Contact+34934978925
RecruitingClinica Universidad de Navarra ( Site 1703)
Madrid, Madrid, Comunidad de, Spain
- Study Coordinator · Contact+34913531920
RecruitingHospital Universitario Reina Sofia ( Site 1702)
Córdoba, Spain
- Study Coordinator · Contact+34 957012408
RecruitingTaichung Veterans General Hospital ( Site 2502)
Taichung, Taiwan
- Study Coordinator · Contact+886423592525
RecruitingNational Cheng Kung University Hospital ( Site 2503)
Tainan, Taiwan
- Study Coordinator · Contact+88662353535
RecruitingKoo Foundation Sun Yat-Sen Cancer Center ( Site 2501)
Taipei, Taiwan
- Study Coordinator · Contact886228970011x1686
Recruiting
Study team
Sponsor
Merck Sharp & Dohme LLC
Study ID 1022-010
Study director
Medical Director
Merck Sharp & Dohme LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.