Back to search results

Study of Patritumab Deruxtecan Plus Pembrolizumab for Early-Stage Breast Cancer

This study is looking for new ways to treat high-risk early-stage triple-negative breast cancer (TNBC) or hormone receptor-low positive/HER2-negative breast cancer. Researchers are testing a combination of patritumab deruxtecan and pembrolizumab (two biological therapies) with standard chemotherapy drugs like paclitaxel, carboplatin, and doxorubicin. The main goals are to see how safe these treatments are, if people can tolerate them, and if adding patritumab deruxtecan to pembrolizumab and chemotherapy before surgery reduces the amount of cancer cells found during surgery. You might be eligible if you are 18 or older and have locally advanced, non-metastatic breast cancer. The study aims to enroll 372 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 372 participants. It is designed to compare different treatment combinations for breast cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety is measured for up to approximately 43 weeks, with dose-limiting toxicities assessed up to 21 days and treatment discontinuation due to side effects measured up to approximately 30 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06797635

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~372 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Patritumab deruxtecanPembrolizumabPaclitaxelCarboplatinDoxorubicin hydrochlorideEpirubicin hydrochloride

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants Experiencing an Adverse Event (AE)
Measured over Up to ~43 weeks
+5 more outcomes measured

Conditions

Breast Neoplasms
Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

17 sites across 12 states
South Korea3
Taiwan3
Texas2
California1
Illinois1
Montana1
Oregon1
Tennessee1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part 1: Number of Participants Experiencing an Adverse Event (AE)Up to ~43 weeks

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented for Part 1.

  • Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)Up to 21 days

    A DLT is defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, assessed by investigator as drug-related: Grade (gr) 3 or 4 nonhematologic toxicity (with exceptions); gr 3 or gr 4 laboratory values (with exceptions); gr 3 or 4 febrile neutropenia; prolonged delay (\>2 weeks) in initiating Cycle 2 (cycle length = 3 weeks) due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during Cycle 1; interstitial lung disease as per investigator; any other gr ≥3 pulmonary toxicity; or gr 5 toxicity.

  • Part 1: Number of Participants who Discontinued Study Treatment Due to an AEUp to ~30 weeks

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinued study treatment due to an AE will be presented for Part 1.

  • Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0Up to ~30 weeks

    pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy at the time of definitive surgery.

  • Part 2: Number of Participants Experiencing an AEUp to ~103 weeks

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented for Part 2.

  • Part 2: Number of Participants who Discontinued Study Treatment Due to an AEUp to ~90 weeks

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinued study treatment due to an AE will be presented for Part 2.