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)

Launched by MERCK SHARP & DOHME LLC · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial, called HERTHENA-Breast-03, is exploring new treatment options for patients with high-risk early-stage breast cancer, specifically those with triple-negative breast cancer (TNBC) or hormone receptor low positive and HER2 negative types. The main aim of the study is to test a combination of three treatments—patritumab deruxtecan, pembrolizumab, and chemotherapy—before surgery, to see if this approach can reduce the number of cancer cells present during surgery compared to those who only receive pembrolizumab and chemotherapy. Researchers will also monitor the safety of these treatments and how well participants tolerate them.

To be eligible for this trial, participants should be adults aged 65 to 74 with locally advanced, non-metastatic breast cancer that meets specific staging criteria. They should have a confirmed diagnosis of either TNBC or the HR-low+/HER2- type and must be in good overall health, as indicated by certain performance and heart function tests. Participants can expect to receive the study treatments and undergo regular monitoring throughout the trial. It's important to note that individuals with certain health conditions or those who have received specific previous treatments may not qualify for participation.

Gender

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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 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