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)
Sponsored by Merck Sharp & Dohme LLC
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.
Where this study is enrolling (8)
- Call 424-402-9520
UCLA Hematology/Oncology - Parkside ( Site 0021)
Santa Monica, California
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- Call 847-568-9932
Orchard Healthcare Research Inc. ( Site 0006)
Skokie, Illinois
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- Call 406-238-6685
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)
Billings, Montana
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- Call 360-944-9889
Northwest Cancer Specialists (Compass Oncology) ( Site 8003)
Tigard, Oregon
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- Call 844-482-4812
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee
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Show all 8 locations
- Call 713.790.3311
Houston Methodist Hospital ( Site 0022)
Houston, Texas
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- Call 214-370-1067
Texas Oncology - DFW ( Site 8000)
Dallas, Texas
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- Call 844-482-4812
Virginia Oncology Associates (VOA) ( Site 8001)
Norfolk, Virginia
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Who can participate
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 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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.