HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
‣ The main inclusion criteria include but are not limited to the following:
⁃ Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
⁃ Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
⁃ Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation
⁃ Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
⁃ Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention
‣ Arm 1:
⁃ Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
⁃ Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment
‣ Arm 2:
• Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
‣ Arm 3:
• Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.
Locations
United States
Massachusetts
Dana-Farber Cancer Institute ( Site 0050)
RECRUITING
Boston
New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0052)
RECRUITING
New Brunswick
South Carolina
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)
RECRUITING
Greenville
Virginia
Inova Schar Cancer Institute ( Site 0051)
RECRUITING
Fairfax
Other Locations
Canada
Jewish General Hospital ( Site 0003)
RECRUITING
Montreal
Princess Margaret Cancer Centre ( Site 0001)
RECRUITING
Toronto
Israel
Rambam Health Care Campus ( Site 0011)
RECRUITING
Haifa
Rabin Medical Center ( Site 0012)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 0010)
RECRUITING
Ramat Gan
Japan
Nagoya City University Hospital ( Site 0020)
RECRUITING
Nagoya
Republic of Korea
Asan Medical Center ( Site 0031)
RECRUITING
Seoul
Seoul National University Hospital ( Site 0030)
RECRUITING
Seoul
United Kingdom
St Bartholomew s Hospital ( Site 0040)
RECRUITING
London
University College London Hospital ( Site 0041)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2025-02-26
Estimated Completion Date:2029-09-10
Participants
Target number of participants:81
Treatments
Experimental: Patritumab deruxtecan plus trastuzumab
Participants receive patritumab deruxtecan intravenous (IV) infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
Experimental: Patritumab deruxtecan plus pertuzumab and trastuzumab
Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
Experimental: Patritumab deruxtecan plus trastuzumab and tucatinib
Participants receive patritumab deruxtecan IV infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks), and tucatinib is administered orally twice daily for each 21-day cycle, until disease progression, intolerable toxicity, or investigator decision.