RecruitingRecruiting
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
NCT06686394 · Merck Sharp & Dohme LLC
In plain English
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Official title
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
About this study
The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.
Eligibility criteria
Inclusion Criteria:
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.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Uncontrolled or significant cardiovascular disease
* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
* Has clinically severe respiratory compromise
* Has any history of or evidence of any current leptomeningeal disease
* Has clinically significant corneal disease
* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
* HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Evidence of spinal cord compression or brain metastases
* Has an active infection requiring systemic therapy
* Concurrent active HBV and HCV infection
* Has had major surgical procedure (excluding placement of vascular access) less than 28 days
Arm 3 ONLY
\- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting
Study design
Enrollment target: 81 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-26
Estimated completion: 2030-04-18
Last updated: 2026-05-22
Interventions
Biological: Patritumab deruxtecanBiological: TrastuzumabBiological: Trastuzumab BiosimilarBiological: PertuzumabBiological: Tucatinib
Primary outcomes
- • Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Up to 21 days)
- • Number of Participants with One or More Adverse Events (AEs) (Up to approximately 13 months)
- • Number of Participants who Discontinue Study Intervention Due to an AE (Up to approximately 12 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: Daiichi Sankyo
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (18)
University of Colorado Anschutz Medical Campus ( Site 0057)Recruiting
Aurora, Colorado, United States
Dana-Farber Cancer Institute ( Site 0050)Recruiting
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey ( Site 0052)Recruiting
New Brunswick, New Jersey, United States
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)Recruiting
Greenville, South Carolina, United States
Inova Schar Cancer Institute ( Site 0051)Recruiting
Fairfax, Virginia, United States
Kingston General Hospital ( Site 0061)Recruiting
Kingston, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0001)Recruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0004)Recruiting
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0003)Recruiting
Montreal, Quebec, Canada
Rambam Health Care Campus ( Site 0011)Recruiting
Haifa, Israel
Rabin Medical Center ( Site 0012)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 0010)Recruiting
Ramat Gan, Israel
Nagoya City University Hospital ( Site 0020)Recruiting
Nagoya, Aichi-ken, Japan
Seoul National University Hospital ( Site 0030)Recruiting
Seoul, South Korea
Asan Medical Center ( Site 0031)Recruiting
Seoul, South Korea
University College London Hospital ( Site 0041)Recruiting
London, Camden, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 0043)Recruiting
Glasgow, Glasgow City, United Kingdom
St Bartholomew s Hospital ( Site 0040)Recruiting
London, London, City of, United Kingdom