Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-02-13
81
Participants Needed
17
Research Sites
268 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed HER2 positive locally advanced unresectable or metastatic breast cancer
- HIV-infected participants must have well-controlled HIV on antiretroviral therapy
- Hepatitis B surface antigen positive participants must have received antiviral therapy for at least 4 weeks and have undetectable viral load
- Participants with history of hepatitis C infection must have undetectable viral load
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days before study start
- Arm 1: Received 2 to 5 prior lines of anti-HER2 therapy in locally advanced or metastatic setting and had disease progression on or after trastuzumab deruxtecan
- Arm 2: Received no more than 5 prior lines of anti-HER2 therapy in locally advanced or metastatic setting
- Arm 3: Received trastuzumab deruxtecan previously with disease progression and no more than 3 prior lines of anti-HER2 therapy; trastuzumab deruxtecan must be most recent therapy before enrollment
You will not qualify if you...
- Uncontrolled or significant cardiovascular disease
- History of noninfectious pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- Clinically severe respiratory compromise
- History or current evidence of leptomeningeal disease
- Clinically significant corneal disease
- Ongoing uncontrolled systemic bacterial, fungal, or viral infection
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Known additional progressing malignancy requiring active treatment within past 3 years
- Evidence of spinal cord compression or brain metastases
- Active infection requiring systemic therapy
- Concurrent active hepatitis B and hepatitis C infection
- Major surgery less than 28 days before study (excluding vascular access placement)
- Arm 3 only: Prior treatment with tucatinib, lapatinib, neratinib, or investigational HER2-targeted tyrosine kinase inhibitors in locally advanced or metastatic setting
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 17 locations
1
Dana-Farber Cancer Institute ( Site 0050)
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
3
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)
Greenville, South Carolina, United States, 29605
Actively Recruiting
4
Inova Schar Cancer Institute ( Site 0051)
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
Kingston General Hospital ( Site 0061)
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
6
Princess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
7
Centre Hospitalier de l'Université de Montréal ( Site 0004)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
8
Jewish General Hospital ( Site 0003)
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
9
Rambam Health Care Campus ( Site 0011)
Haifa, Israel, 3109601
Actively Recruiting
10
Rabin Medical Center ( Site 0012)
Petah Tikva, Israel, 4941492
Actively Recruiting
11
Sheba Medical Center ( Site 0010)
Ramat Gan, Israel, 5265601
Actively Recruiting
12
Nagoya City University Hospital ( Site 0020)
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
13
Seoul National University Hospital ( Site 0030)
Seoul, South Korea, 03080
Actively Recruiting
14
Asan Medical Center ( Site 0031)
Seoul, South Korea, 05505
Actively Recruiting
15
University College London Hospital ( Site 0041)
London, Camden, United Kingdom, NW1 2PG
Actively Recruiting
16
The Beatson West of Scotland Cancer Centre ( Site 0043)
Glasgow, Glasgow City, United Kingdom, G12 0YN
Actively Recruiting
17
St Bartholomew s Hospital ( Site 0040)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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