RecruitingPhase 1Phase 2NCT06686394

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)

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

Sponsor

Merck Sharp & Dohme LLC

Enrollment

81 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Neoplasms

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests patritumab deruxtecan (an antibody-drug combination that targets HER3) alone or combined with other cancer drugs in people with HER2-positive breast cancer that has spread and cannot be surgically removed. **You may be eligible if...** - You have HER2-positive breast cancer that has spread (locally advanced or metastatic) - You have received prior anti-HER2 therapies (specific number varies by treatment arm) - You are physically functional (ECOG 0–1) - If you have HIV, hepatitis B, or hepatitis C, these must be well-controlled on treatment **You may NOT be eligible if...** - You have uncontrolled heart disease - You have a history of serious lung inflammation (interstitial lung disease or pneumonitis) - You have active serious infections - You have brain or spinal cord metastases - You have had major surgery in the past 28 days - You have active leptomeningeal disease (cancer involving the lining of the brain/spine) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPatritumab deruxtecan

Patritumab deruxtecan administered via IV infusion

BIOLOGICALTrastuzumab

Trastuzumab administered via IV infusion

BIOLOGICALTrastuzumab Biosimilar

Trastuzumab biosimilar administered via IV infusion

BIOLOGICALPertuzumab

Pertuzumab administered via IV infusion

BIOLOGICALTucatinib

Tucatinib administered as oral tablets

Locations(17)

Dana-Farber Cancer Institute ( Site 0050)

Boston, Massachusetts, United States

Rutgers Cancer Institute of New Jersey ( Site 0052)

New Brunswick, New Jersey, United States

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

Greenville, South Carolina, United States

Inova Schar Cancer Institute ( Site 0051)

Fairfax, Virginia, United States

Kingston General Hospital ( Site 0061)

Kingston, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0001)

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0003)

Montreal, Quebec, Canada

Rambam Health Care Campus ( Site 0011)

Haifa, Israel

Rabin Medical Center ( Site 0012)

Petah Tikva, Israel

Sheba Medical Center ( Site 0010)

Ramat Gan, Israel

Nagoya City University Hospital ( Site 0020)

Nagoya, Aichi-ken, Japan

Seoul National University Hospital ( Site 0030)

Seoul, South Korea

Asan Medical Center ( Site 0031)

Seoul, South Korea

University College London Hospital ( Site 0041)

London, Camden, United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 0043)

Glasgow, Glasgow City, United Kingdom

St Bartholomew s Hospital ( Site 0040)

London, London, City of, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06686394

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