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)

Last updated: April 21, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

Epirubicin hydrochloride

Capecitabine

Olaparib

Clinical Study ID

NCT06797635
1022-010
U1111-1307-7867
2024-514376-40
MK-1022-010
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thefollowing combined primary tumor (T) and regional lymph node (N) staging per currentAmerican 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 orHR-low+/HER2- breast cancer that will be treated according to the triple-negativebreast cancer (TNBC) paradigm

  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV viral load

  • Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCVviral 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

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has uncontrolled or significant cardiovascular disease before randomization

  • Has clinically significant corneal disease

  • Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcomaand/or multicentric Castleman disease

  • Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, oranti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitoryT-cell receptor

  • Has received any prior treatment, including radiation, systemic therapy, and/ordefinitive 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 exatecanderivative 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 treatmentwithin the past 5 years

  • Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis

  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease, or where suspectedILD/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 pulmonaryillness

Study Design

Total Participants: 372
Treatment Group(s): 9
Primary Treatment: Epirubicin hydrochloride
Phase: 2
Study Start date:
March 20, 2025
Estimated Completion Date:
December 31, 2034

Connect with a study center

  • Orchard Healthcare Research Inc. ( Site 0006)

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)

    Billings, Montana 59102
    United States

    Active - Recruiting

  • Northwest Cancer Specialists (Compass Oncology) ( Site 8003)

    Tigard, Oregon 97223
    United States

    Active - Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology - DFW ( Site 8000)

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Virginia Oncology Associates (VOA) ( Site 8001)

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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