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NCT06797635 · ClinicalTrials.gov registry record · 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)
A Phase 2 study of Breast Cancer and Breast Neoplasms, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 372
- Enrollment target
- 17
- Study locations
NCT06797635: Recruiting Phase 2 study of Breast Cancer and Breast Neoplasms, sponsored by Merck Sharp & Dohme.
NCT06797635 is a Phase 2 study of Breast Cancer and Breast Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 372 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (87% lower). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06797635, a Phase 2 study of Breast Cancer and Breast Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 372 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2025-03-20 |
| Est. Completion | 2034-12-31 |
| Phase | Phase 2 |
What NCT06797635 shows while recruiting
NCT06797635 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (87% lower).
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.
NCT06797635 lists 17 locations in 10 states (Other, Texas, California).
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.
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).
Who is sponsoring clinical trial NCT06797635?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06797635's enrollment target sits among peer trials
372 251st of 1224 higher than 974 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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