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RECRUITING Phase 2 ClinicalTrials.gov

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)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06797635

Registry updated: 2026-09-10
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Description

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.

Interventions

  • Patritumab deruxtecan (Biological)
    Administered via IV infusion as neoadjuvant treatment
  • Pembrolizumab (Biological)
    Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2
  • Paclitaxel (Drug)
    Administered via IV infusion as neoadjuvant treatment
  • Carboplatin (Drug)
    Administered via IV infusion as neoadjuvant treatment
  • Doxorubicin hydrochloride (Drug)
    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 (Drug)
    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 (Drug)
    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 (Drug)
    Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2
  • Olaparib (Drug)
    Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2

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 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

Conditions

Breast Neoplasms Breast Cancer

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record