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RECRUITING
NCT06797635
PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

372

Start Date

2025-03-20

Completion Date

2034-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

Patritumab deruxtecan

Administered via IV infusion as neoadjuvant treatment

BIOLOGICAL

Pembrolizumab

Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2

DRUG

Paclitaxel

Administered via IV infusion as neoadjuvant treatment

DRUG

Carboplatin

Administered via IV infusion as neoadjuvant treatment

DRUG

Doxorubicin hydrochloride

Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2

DRUG

Epirubicin hydrochloride

Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2

DRUG

Cyclophosphamide

Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2

DRUG

Capecitabine

Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2

DRUG

Olaparib

Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2

Locations (17)

UCLA Hematology/Oncology - Parkside ( Site 0021)

Santa Monica, California, United States

Orchard Healthcare Research Inc. ( Site 0006)

Skokie, Illinois, United States

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

Billings, Montana, United States

Northwest Cancer Specialists (Compass Oncology) ( Site 8003)

Tigard, Oregon, United States

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, United States

Texas Oncology - DFW ( Site 8000)

Dallas, Texas, United States

Houston Methodist Hospital ( Site 0022)

Houston, Texas, United States

Virginia Oncology Associates (VOA) ( Site 8001)

Norfolk, Virginia, United States

Seoul National University Hospital ( Site 2400)

Seoul, South Korea

Severance Hospital, Yonsei University Health System ( Site 2402)

Seoul, South Korea

Asan Medical Center ( Site 2401)

Seoul, South Korea

Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)

Badalona, Catalonia, Spain

Clinica Universidad de Navarra ( Site 1703)

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario Reina Sofia ( Site 1702)

Córdoba, Spain

Taichung Veterans General Hospital ( Site 2502)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 2503)

Tainan, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)

Taipei, Taiwan