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NCT06686394PHASE1, PHASE2Recruiting

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)

Merck Sharp & Dohme LLC

Start Date

2/26/2025

Completion Date

4/18/2030

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

Detailed Description

The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Patritumab deruxtecan

BIOLOGICAL

Trastuzumab

BIOLOGICAL

Trastuzumab Biosimilar

BIOLOGICAL

Pertuzumab

BIOLOGICAL

Tucatinib

Interested in This Trial?

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Conditions

Breast NeoplasmsBreast Cancer

Locations

University of Colorado Anschutz Medical Campus ( Site 0057)

Aurora, Colorado 80045

United States

Dana-Farber Cancer Institute ( Site 0050)

Boston, Massachusetts 02215

United States

Rutgers Cancer Institute of New Jersey ( Site 0052)

New Brunswick, New Jersey 08901

United States

Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)

Greenville, South Carolina 29605

United States

Inova Schar Cancer Institute ( Site 0051)

Fairfax, Virginia 22031

United States

Kingston General Hospital ( Site 0061)

Kingston, Ontario K7L 2V7

Canada

Princess Margaret Cancer Centre ( Site 0001)

Toronto, Ontario M5G 2M9

Canada

Centre Hospitalier de l'Université de Montréal ( Site 0004)

Montreal, Quebec H2X 3E4

Canada

Jewish General Hospital ( Site 0003)

Montreal, Quebec H3T 1E2

Canada

Rambam Health Care Campus ( Site 0011)

Haifa, 3109601

Israel

Rabin Medical Center ( Site 0012)

Petah Tikva, 4941492

Israel

Sheba Medical Center ( Site 0010)

Ramat Gan, 5265601

Israel

Nagoya City University Hospital ( Site 0020)

Nagoya, Aichi-ken 467-8602

Japan

Seoul National University Hospital ( Site 0030)

Seoul, 03080

South Korea

Asan Medical Center ( Site 0031)

Seoul, 05505

South Korea

University College London Hospital ( Site 0041)

London, Camden NW1 2PG

United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 0043)

Glasgow, Glasgow City G12 0YN

United Kingdom

St Bartholomew s Hospital ( Site 0040)

London, London, City of EC1A 7BE

United Kingdom