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)
An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCLA Hematology/Oncology - Parkside ( Site 0021) — Santa Monica, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- UCLA Hematology/Oncology - Parkside ( Site 0021) — Santa Monica, California
- Orchard Healthcare Research Inc. ( Site 0006) — Skokie, Illinois
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003) — Billings, Montana
- Northwest Cancer Specialists (Compass Oncology) ( Site 8003) — Tigard, Oregon
- SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee
- Texas Oncology - DFW ( Site 8000) — Dallas, Texas
- Houston Methodist Hospital ( Site 0022) — Houston, Texas
- Virginia Oncology Associates (VOA) ( Site 8001) — Norfolk, Virginia
- Seoul National University Hospital ( Site 2400) — Seoul,
- Severance Hospital, Yonsei University Health System ( Site 2402) — Seoul,
- Asan Medical Center ( Site 2401) — Seoul,
- Institut Català d'Oncologia (ICO) - Badalona ( Site 1700) — Badalona, Catalonia
- Clinica Universidad de Navarra ( Site 1703) — Madrid, Madrid, Comunidad de
- 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,
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.