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)

PHASE2RecruitingINTERVENTIONAL
Enrollment

372

Participants

Timeline

Start Date

March 20, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2034

Conditions
Breast NeoplasmsBreast Cancer
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

Trial Locations (12)

112

RECRUITING

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

407

RECRUITING

Taichung Veterans General Hospital ( Site 2502), Taichung

704

RECRUITING

National Cheng Kung University Hospital ( Site 2503), Tainan City

23502

RECRUITING

Virginia Oncology Associates (VOA) ( Site 8001), Norfolk

37203

RECRUITING

SCRI Oncology Partners ( Site 7000), Nashville

59102

RECRUITING

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

60077

RECRUITING

Orchard Healthcare Research Inc. ( Site 0006), Skokie

75246

RECRUITING

Texas Oncology - DFW ( Site 8000), Dallas

77030

RECRUITING

Houston Methodist Hospital ( Site 0022), Houston

90404

RECRUITING

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

97223

RECRUITING

Northwest Cancer Specialists (Compass Oncology) ( Site 8003), Tigard

03080

RECRUITING

Seoul National University Hospital ( Site 2400), Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY