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RECRUITING Phase 2

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)

NCT06797635 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Carboplatin
  • DRUG Paclitaxel
  • BIOLOGICAL Patritumab deruxtecan
  • DRUG Doxorubicin hydrochloride

Study Locations (17)

Other

  • Seoul National University Hospital ( Site 2400) — Seoul
  • Severance Hospital, Yonsei University Health System ( Site 2402) — Seoul
  • Asan Medical Center ( Site 2401) — Seoul
  • Hospital Universitario Reina Sofia ( Site 1702) — Córdoba
  • Taichung Veterans General Hospital ( Site 2502) — Taichung
  • National Cheng Kung University Hospital ( Site 2503) — Tainan
  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501) — Taipei

Texas

  • Texas Oncology - DFW ( Site 8000) — Dallas
  • Houston Methodist Hospital ( Site 0022) — Houston

California

  • UCLA Hematology/Oncology - Parkside ( Site 0021) — Santa Monica

Illinois

  • Orchard Healthcare Research Inc. ( Site 0006) — Skokie

Montana

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

Oregon

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

Tennessee

  • SCRI Oncology Partners ( Site 7000) — Nashville

Virginia

  • Virginia Oncology Associates (VOA) ( Site 8001) — Norfolk

Trial Details

FieldValue
Enrollment Target 372 participants
Start Date 2025-03-20
Est. Completion 2034-12-31
Phase Phase 2

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06797635

The ClinicalTrials.gov registry entry for NCT06797635 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 372 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06797635 reports 17 study locations spanning 10 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06797635 about?

NCT06797635 is a clinical study titled "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)". 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 toler...

What is the current status of trial NCT06797635?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 372 participants. The study started on 2025-03-20. Estimated completion is 2034-12-31.

What conditions does trial NCT06797635 study?

This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06797635?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Paclitaxel (DRUG), Patritumab deruxtecan (BIOLOGICAL), Doxorubicin hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06797635?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06797635 being conducted?

This trial has 17 study locations across California, Illinois, Montana, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial